LF5MICSIMPLANT3Medical implant that is internal to the human body

ECOMarket ReleaseDBL:xxxxxxxxxxx Printinginstructions:doc# xxxxxx; refer to ’Implant manuals’ row in the applicable table. ThefollowingaretrademarksofMedtronic. Active Can,CapSure, CardiacCompass, Flashback, GEM,GEMDR,MarkerChannel, Marquis II, Medtronic, PR Logic, Patient Alert, Quick Look, Sigma 198483001CMedtronicConfidentialComposed: xxxx-xx-xx11:48 MedtronCRMB ,Cxxxx-xx-xx ECOMarket ReleaseDBL:xxxxxxxxxx Printinginstructions:doc#xxxxxxx; refer to ’Implant manuals’ row in the applicable table. TableofContents 1Description3 2Indicationsandusage3 3Contraindications3 4Warningsandprecautions3 4.1Storageandhandling4 4.2Resterilization4 4.3Deviceoperation4 4.4Leadevaluationandleadconnection5 4.5Follow-uptesting5 4.6Explantanddisposal6 4.7Medicaltherapy hazards6 4.8Homeandoccupationalenvironments7 5Adverseevents8 5.1Observedadverseevents8 5.2Potentialadverseevents10 6Clinicalstudies11 6.1Acutestudy11 6.2Implantstudy11 7Patientselectionandtreatment15 7.1Individualizationoftreatment15 7.2Specificpatientpopulations15 8Patientcounselinginformation16 9Conformancetostandards16 10How supplied16 11Clinicianuseinformation16 11.1Physiciantraining16 11.2Directionsforuse16 11.3Maintainingdeviceeffectiveness17 12Patientinformation17 13Implantprocedure17 13.1Pre-operative programming18 13.2Testingleadoperation18 13.3Connectingleadstotheimplanteddevice19 13.4Defibrillationthresholdtesting20 13.5Placingthedevice21 13.6Programming21 13.7ReplacinganoldICD21 14Featuresummary22 14.1Tachyarrhythmiaoperations22 14.2Pacingoperations22 1 198483001CMedtronicConfidentialComposed:2xxxx-xx-xx11:48 MedtronCRMB,Cxxxxx-xx-xx ECOMarket ReleaseDBL:xxxxxxxxxxx Printinginstructions:doc#xxxxxx; refer to ’Implant manuals’ row in the applicable table. 14.3Monitoringoperations23 15Productspecifications23 15.1Physicalspecifications(nominal)23 15.2Replacementindicators23 15.3Projectedlongevity24 15.4Magnetbehavior26 15.5Functionalparameters26 2 198483001CMedtronicConfidentialComposed: xxxx-xx-xx11:48 MedtronCRMB ,Cxxxx-xx-xx ECOMarket ReleaseDBL:xxxxxxxxxxx Printinginstructions:doc#xxxxxx; refer to ’Implant manuals’ row in the applicable table. 1Description TheMode lXXXXMarquis IIDR Implantable Cardioverter Defibrillator (ICD) System is a multiprogrammable, implantable cardioverterdefibrillatorthatmonitorsandregulatesa patient’s heart rateby providingventricular arrhythmiatherapy, andsingleordualchamberrateresponsive bradycardiapacing. TheModel XXXXMarquisII DR ICD, along with commercially available pace/sense leads and cardioversion/ defibrillationleads, constitutestheimplantable portionoftheICDsystem.Theleadsystemsforthe Marquis IIDR system are implanted using standard transvenous placement techniques. TheModel9790Cprogrammer, Model9966software, Model9466patientmagnet,Model9322SmartMagnet andModel9767(orModel9767L)programmingheadconstitute oneexternal portion of the ICD system. The Model 2090 programmer is compatible. Programmers from other manufacturers are not compatible. Contentsofsterilepackage–Thesterilepackagecontainsoneimplantable cardioverterdefibrillator, one torquewrench,andoneDF–1pinplug. Aboutthismanual–Thisdocumentis intendedprimarilyasanimplantmanual.Regularpatient follow-upsessionsshouldbescheduledafterimplant.Follow-upproceduressuchasmonitoringbattery measurementsandconfirmingtherapy parametersaredescribedin themanualincludedwiththesoftware supportingtheModel XXXXMarquisII DR ICD. (To obtain additional copies of this manual, contact your Medtronicrepresentative.) 2Indicationsandusage Theimplantable cardioverterdefibrillatoris intendedtoprovideventricularantitachycardiapacingand ventriculardefibrillationforautomatedtreatmentoflife threateningventriculararrhythmias. 3Contraindications TheMarquis IIDR system is contraindicated for • patientswhosetachyarrhythmiasmay have transientorreversible causes, suchas:acutemyocardial infarction,digitalisintoxication,drowning,electrocution,electrolyteimbalance, hypoxia,orsepsis. • patientswithincessantVTorVF • patientswhohave a unipolarpacemaker • patientswhoseprimary disorderis bradyarrhythmiasoratrialarrhythmias 4Warningsandprecautions Avoidingshock duringhandling–ProgramtachyarrhythmiadetectionOffduringsurgicalimplantand explantorpost-mortemproceduresbecausetheICDcandelivera seriousshock if youtouchthedefibrillation terminalswhiletheICDis charged. Electricalisolationduringimplantation–Donotpermitthepatienttocontactgroundedequipment, whichcouldproducehazardousleakagecurrentduringimplantation.Resultingarrhythmiainductioncould resultin thepatient’sdeath. Leadsystem–Donotuseanothermanufacturer’sleadsystemwithoutdemonstratedcompatibility, as undersensingofcardiacactivityandfailuretodelivernecessary therapy couldresult. Resuscitationavailability–DonotperformICDtestingunlessanexternaldefibrillatorandmedical personnelskilledin cardiopulmonary resuscitation(CPR)arereadilyavailable. 3 198483001CMedtronicConfidentialComposed:2xxxx-xx-xx11:48 MedtronCRMB,C xxxx-xx-xx ECOMarket ReleaseDBL:xxxxxxxxxxxx Printinginstructions:doc#xxxxrefer to ’Implant manuals’ row in the applicable table. 4.1Storage andhandling Checkingandopeningthepackage–Beforeopeningthesterilepackagetray, visuallycheck forany signs ofdamagethatmightinvalidatethesterilityofitscontents. Return damagedpackagestothemanufacturer. Forinstructionsonopeningthesterilepackage, seethediagraminsidethelidof theshelfbox. Devicestorage–Storethedevicein a cleanarea,away frommagnets, kitscontainingmagnets, and sourcesofelectromagneticinterferencetoavoiddevicedamage. Droppeddevice–Donotimplantthedeviceif it hasbeendroppedona hardsurfacefroma heightof 30cm (12in)ormoreafterremoval fromitspackaging. Equilibration–Allow thedevicetoreachroomtemperaturebeforeprogrammingorimplanting,because rapidtemperaturechangescouldaffectinitialdevicefunction. Temperaturelimits–Storeandtransport thepackagebetween-18 C (0 F)and+55 C (+131 F). “UseBy”Date–Donotimplantthedeviceafterthe“UseBy”datebecausethebattery longevitycould bereduced. 4.2Resterilizati…

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June 1, 2012 Federal Communications Commission Laboratory Division 7435 Oakland Mills Road Columbia, MD 21045 In re: Application for certification of a Medical Implant Transceiver FCC ID:LF5MICSIMPLANT3 Dear Sir or Madam: Submitted herewith on behalf of Medtronic Incorporated, 710 Medtronic Parkway, Minneapolis, Minnesota 55432, is an application for an implant to be used in a medical implant communications system that operates in the Medical Implant Communications Service (MICS) band from 402 to 405 MHz under Part 95 of the FCC Rules and Regulations. This application contains a separate request for post grant confidential treatment of certain portions of the application material as identified in that letter. Medtronic is requesting that the application be processed in a timely manner with the actual grant of equipment authorization to be deferred, pursuant to Section 0.457(d)(1)(ii), until the date specified on the application for equipment authorization, Form 731, or alternatively, to an earlier date to be specified by Medtronic Inc., via written or email correspondence to the Chief, Equipment Authorization Branch. Deferral of the grant date is requested in order to allow the grant to be coordinated with the public release of the start of clinical evaluation of the product by the Food and Drug Administration (FDA). Medical products, such as this new implant technology, require development a pre-market clinical approval regimen through a negotiated process between the manufacture and the FDA. These negotiations and developed of the required testing protocols typically take anywhere from 6 to 18 months or in rare instances, longer. Thus Medtronic is requesting deferral for an extended period of time due to the uncertainty associated with the FDA pre-market product approval process. Pursuant to Section 95.1217, the FCC ID number associated with the transmitter and the information required by Section 2.925 of the FCC Rules will be placed in the instruction manual for the transmitter and on the shipping container for the transmitter, in lieu of being placed directly on the transmitter. The application contains a separate attachment showing the format of the information to be placed in the manual. Each implant is given a specific serial number that is permanently encoded in the electronics contained on the internal printed circuit board. Sincerely, Phillip Inglis Consultant to Medtronic. TRP Inc. 14085 Howard Rd Dayton, MD 21036

May 2, 2012 VIA ELECTRONIC FILIING Equipment Authorization Branch Federal Communications Commission Columbia, MD 21046 Re: Medtronic, Inc. Request For Confidentiality FCC ID No.:LF5MICSIMPLANT3 Ladies and Gentlemen: Medtronic, Inc. (“Medtronic”) requests that the information contained in the items enumerated below pertaining to the above-referenced application be withheld from public disclosure in accordance with Sections 0.457 and 0.459 of the Commission’s Rules, 47 C.F.R. following grant of the application. In support of this request, Medtronic submits the following: (1) identification of the specific information for which confidential treatment is sought: Schematics Parts List Block Diagram Internal Photographs Operational Description The materials set forth in these exhibits, which are segregated from the non- confidential exhibits of the application, are those for which confidentiality is sought. (2) identification of the Commission proceeding in which the information was submitted or a description of the circumstances giving rise to the submission: The proceeding is that involving the application for and certification request for FCC ID No.: LF5MICSIMPLANT3. (3) explanation of the degree to which the information is commercial or financial, or contains a trade secret or is privileged: This information is embodied in circuit diagrams, detailed explanations, parts lists, a block diagram and internal photographs of a sealed device designed for implantation in humans. As such, this material is treated as highly confidential Equipment Authorization Branch May 2, 2012 Page 2 business information and information that could convey trade secrets pertaining to manufacturing and design techniques. (4) explanation of the degree to which the information concerns a service that is subject to competition: The information for which confidentiality is sought is employed in the design and manufacture of medical implant devices that are offered on a highly competitive basis. Customers for this equipment have a variety of competing sources of supply from both domestic and foreign suppliers. (5) explanation of how disclosure of the information could result in substantial competitive harm: Disclosure would, in effect, give away the fruits of the labors of Medtronic’s engineering personnel, who have designed the equipment and the manufacturing processes. Disclosure would also offer competitors additional unwarranted insight into the state of product development thereby allowing such competitors an advantage that would not be available to Medtronic. (6) identification of any measures taken by the submitting party to prevent unauthorized disclosure: The information for which confidential treatment is sought is kept confidential by Medtronic and not made available to third parties except pursuant to arrangements designed to prevent public disclosure. (7) identification of whether the information is available to the public and the extent of any previous disclosure of the information to third parties: To the knowledge of those preparing this application, the information has not been disclosed publicly heretofore. The protection sought is narrowly drawn and pertains to certain specific implementations of the technology incorporated into the device for which certification is sought.. (8) justification of the period during which the submitting party asserts that material should not be available for public disclosure: This material should not be disclosed for at least ten years. While improvements in design are likely to be made during this period, disclosure of the design information would lead to insights into both designs and manufacturing techniques and could have an adverse competitive effect for many years to come. This application contains information that will be used in future applications for similar devices. Moreover, the communications aspects of this device are employed in the programming of a medical implant device and in the transmission of highly private medical information to and from the device. Disclosure of the information for which Equipment Authorization Branch May 2, 2012 Page 3 confidentiality is sought could jeopardize the protection of such personal private medical information generated for the benefit of patients into whom the device has been implanted. As such, it is important that information pertaining to the design and operation of this device not be made available to unauthorized persons who might attempt to use knowledge of the design to compromise the applications for which the equipment will be employed. (9) any other information that the party seeking confidential treatment believes may be useful in assessing whether its request for confidentiality should be granted: See item 8 above. Note that the equipment for which approval is being sought will be employed in applications that inherently carry a premium on security. Respectfully, Phillip Inglis Consultant for Medtronic, Inc.

1) The exhibit "Signed confidentiality request letter" at item (2) mentions fccid L5FMICSIMPLANT2, which seems not applicable; please submit revised letter as appropriate. REPLY: Revised letter submitted 2) User manual exhibit mentions fccid L5FMICSIMPLANT2, which seems not applicable; please revise as appropriate. REPLY: Revised manual submitted 3) Op. desc. mentions "MICS" and "MEDS"; fyi those terms are obsolete for the purposes of FCC authorizations and operations. Although revision is not required for this filing, for all future filings for similar devices please ensure to use descriptions consistent with rules versions in effect at the time of application submissions; i.e. in this case being MedRadio. REPLY: Understood 4) fyi we note that op. desc. mention of "The Transmitter outlined in Figure 22 ..." appears to be typo, i.e. should refer to Fig. 23. REPLY: Typo corrected and re-submitted. 5) For exhibit entitled "ID label in Manual", strictly speaking the disclosure statement therein is not consistent with 95.1215(a), i.e. CFR has "Radiocommunication" not "Radiocommunications"; where appropriate please revise. REPLY: Revised label submitted. 6) Exhibits herein mention variously Viva, Aria, Brava, Evera, Marquis II; unless already in the filing, please provide summary list of models and with brief descriptions of each for all versions intended to be covered under this FCC ID. REPLY: As shown in the Test Report, the models to which the radio frequency data is applicable are: Viva Quad / Viva Quad C / Viva Quad XT / Viva Quad S / Brava Quad / Viva XT / Viva S / Brava / Evera XT / Evera S. The RF UHF radio system is the same in all models to be covered under this FCC ID. The difference is that each model has a specific type of therapy delivery that is targeted to the patient condition. 7) User manual has the following. The Model 9790C programmer, Model 9966 software, Model 9466 patient magnet, Model 9322 SmartMagnet and Model 9767 (or Model 9767L) programming head constitute one external portion of the ICD system. The Model 2090 programmer is compatible. For reference purposes please list FCC IDs for any other intentional radiator devices among these that can operate as part of a system with FCC ID LF5MICSIMPLANT3. REPLY: The manual is a draft manual that contains models referencing older inductive devices. The following FCC ID’s apply to devices that can be used with the above referenced FCC ID:LFTMICSIMPLANT3 in the MedRadio Communications Service. FCC ID: LF5MICS, LF5MICSW, LF5MICSW2. 8) Further also to preceding item 7), in case LF5MICSIMPLANT3 contains also any inductive telemetry transmit function, if not in this filing already please provide a brief description of such transmit mode [freq., nominal antenna feed-point power, antenna descrip., 15.31(h) all- antennas-emitting compliance, etc.]. REPLY: The subject FCC ID device or devices contain an inductive telemetry system transmitting on 175 kHz using FSK modulation with a loop antenna that is enclosed within the metallic implant housing. The inductive system operates under the provisions of 15.209 and radiates at a field strength level that is 40 dB or more below the applicable limit. As such units covered by the subject FCC ID are exempt from certification under 15.201(a) of the FCC Rules. 9) EMC report has measured complex permittivity for human body simulator; if not in the filing already, please provide target values used for complex permittivity and source / pub. reference for those; also please describe recipe for the tissue simulating liquid. REPLY: Target values were taken from a program on the FCC website specifically for 403.5 MHz. The target values were for muscle at 403.5 MHz: conductivity - 0.839, relative permittivity – 58.79 The formula used by Medtronic for mixing the tissue substitute material is below. Medtronic provides the tissue substitute material to the test house for conducting tests. Upon completion of mixing, the tissue characteristics are measured. Final values for conductivity and relative permittivity were 0.89 and 58.9 respectively and were measured on a HP network analyzer with a dielectric probe. 10) EMC report mentions 95.628(g)(3), 95.628(i) [sic], 95.635(d)(4-5); fyi 47 CFR version at the time of submission is renumbered to 95.627(g)(3), 95.627(g)(3)(i), 95.635(d)(4), respectively. REPLY: Noted 11) EMC report describes "field strength of fundamental," however the applicable limit is 25 uW EIRP from 95.639(f)(1) [also 18.2 mV/m, per 95.627(g)(3)]. To support uniform comparison across like applications, test results must be reported in terms of actual rule limit values and units. Furthermore in general test reports should include sample calculations showing how measurement results were converted for comparison with the technical requirements. Please revise accordingly to explicitly report compliance for 95.639(f)(1) in terms of microwatts EIRP, and including sample calculations if converting from dBuV/m. REPLY: The following EIRP value was calculated from the maximum measured field strength level of 61.7 dBuV/m measured at 3 meters by Northwest EMC. Converting 61.7 dBuV/m to uV/m yields a level of 1216.1 uV/m. Accounting for reflected component , according to information in the original MICS rule making procedure, we need to subtract 6 dB giving 608 uV/m for the direct ray. Using E=√30xP/ 3 Solving for power, P=110.9 nWatt EIRP 12) EMC report has identified several part 95 rules sections used for compliance demonstration; note also that 2.1033(c)(14) requires demonstrating compliance for 2.1046 to 2.1057. Per 2.911(b), compliance must be documented for both 2.1033(c)(14) and part 95; please revise EMC report accordingly. REPLY: A cross reference between the Part 2 and Part 95 testing requirements has been provided via separate file that has been uploaded to the server showing all requirements of both sections are addressed. 13) EMC report describes receiver spurious emissions per 15.109. Per 1…

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14085 Howard Rd Dayton MD 21036 July 31, 2012 Federal Communications Commission Laboratory Division 7435 Oakland Mills Road Columbia, MD 21045 In re: Request for application for certification of FCC ID:LF5MICSIMPLANT3 to be issued immediately upon completion of technical review. Dear Mr. Dichoso: The application for certification of the reference FCC ID was submitted to the Laboratory on May 2, 2012. That application requested a delay in issuance of the applied for grant of certification for the referenced FCC ID until 9/30/12. Via this letter, Medtronic is requesting the Grant for FCC ID:LF5MICSIMPLANT3, be issued immediately upon completion of the technical review. Medtronic also acknowledges/confirms that the following request will cancel the Deferred (DF) request dated 9/30/12 as stated in the original application. Sincerely, Phillip Inglis Consultant to Medtronic. TRP Inc.

Device Photos

SIZE PART NUMBER REV SHEET A3 TITLE X.X ± X.XX ± X.XXX ± ANGLES ± MODEL UNLESS OTHERWISE SPECIFIED ALL DIMENSIONS ARE IN INCHES FIRST DESIGNED FOR TYPE PP MEDTRONIC, INC. MINNEAPOLIS, MINNESOTA USA SCALE DRAFTING DATE ENGINEERING D E S I G N D O C U M E N T MEDTRONIC CONFIDENTIAL THIS DOCUMENT IS THE PROPERTY OFMEDTRONIC, INC. AND MUST BE ACCOUNTED FOR. INFORMATION HEREON IS CONFIDENTIAL. DO NOT REPRODUCE IT, REVEAL IT TO UNAUTHORIZED PERSONS OR SEND IT OUTSIDE MEDTRONIC WITHOUT PROPER AUTHORIZATION. THE ADOBE FILE FOR THIS PRINT CAN BE MADE AVAILABLE UPON REQUEST N/A JUDY SALZER JUDY SALZER 18APR12 DTBB2D1 A53819 B1 of 3 LABEL IMAGE SPEC - VIVA S CRT-D DTBB2D1 OUS -.- -.-- -.--- ---° 1. THE IMAGES ATTACHED ARE A REPRESENTATION OF THE FINAL OUS MARKET DTBB2D1 PACKAGE LABELS. THEY REPRESENT HOW THE LABELS APPEAR PRINTED ON ONE LASER SET OR SEPARATE LABELS. 2. THESE LABEL IMAGES ARE THE COMBINATIONS OF THE FORMSCAPE TEMPLATE FILE, PDPS MODEL DATA RECORD, SAMPLE TRIGGER DATA AND REPRESENTATIVE VIEWS OF THE LABEL DIE LINES. 3. THE SERIAL NUMBER, USE BY DATE, DATE OF MANUFACTURE, PIN NUMBER, REF NUMBER AND BAR CODES ARE SHOWN FOR EXAMPLE ONLY. THESE FIELDS ARE VARIABLE AND ARE TO BE SUPPLIED BY MANUFACTURING AT THE TIME OF PRINTING. 4. THE LABEL SET IS TO BE PRINTED USING A 600 DPI LASER JET PRINTER OR EQUIVALENT AND THE INDIVIDUAL LABELS ARE TO BE PRINTED USING A 300 DPI ZEBRA THERMAL TRANSFER PRINTER. 5. THE TRIGGER DATA SHOWN ON THE LABEL SET IMAGE MAY NOT MATCH THE PRINTED LABEL. 6. SPACING AND TEXT WRAPPING SHOWN IN THE IMAGE MAY DIFFER SLIGHTLY FROM ACTUAL PRINTED LABEL. CONTENT OF PRINTED VERSION IS ACCURATE. 7. THE LABEL PRINTED IN MANUFACTURING MUST BE AT AN EQUAL OR LATER MODEL DATA AND TEMPLATE REVISION AS SHOWN ON THE IMAGE. 8. THIS SPECIFICATION IS CONTROLLED BY CRDM PACKAGE ENGINEERING. SPEC TAB LASER SETSINGLE LABELS MFG ADDRESS A53819-001 A53819-002 X X Juncos, Puerto Rico, USA Tolochenaz, Switzerland PART NUMBER REV SHEET A53819 B2 of 3 A53819-001 SPEC TAB UNIVERSAL LABEL SET (DEVICES) Rev.: X LOT NUMBER MONTH YEAR * A 1 4 6 3 2 0 0 1 * Viva™ S CRT-D DTBB2D1 DDE-DDDR M950713A001 A - M950734A001 B DDD 130 min -1 50 min -1 Upper tracking rate and lower rate line space space0.3 mV Sensitivity: RA line space space0.3 mV Sensitivity: RV line space 130 ms100 ms A-V interval (paced and sensed) line space 3.5 V } 0.4 ms } Amplitude and pulse width: RA Adaptive 3.5 V } 0.4 ms } Amplitude and pulse width: RV line space 4.0 V } 0.4 ms Amplitude and pulse width: LV line space spaceLVtip / RVcoil Pace polarity: LV line space LV->RV0 ms V pacing and V-V pace delay line space spaceOFF Detection: VT, FVT, VF N13571Z813 WWW000000W YYYY-MM-DD 2000-00-00 Radio compliance 2000-00 YYYY-MM Medtronic, Inc., 710 Medtronic ParkwayMinneapolis, MN 55432 USA Manufactured in:Juncos, Puerto Rico, USA Medtronic B.V., Earl Bakkenstraat 106422 PJ Heerlen, The Netherlandswww.medtronic.com FCC ID: LF5MICSIMPLANT3IC: 3408D-MIMPLANT3Product of USA Defibrillation AV cardioversion Burst: RV, LV Burst+: RA Ramp: RA, RV, LV Ramp+: RV, LV 50 Hz Burst: RA spaceOFF Therapies (RV): VT, FVT line space space35/42 J Therapies (delivered and stored): VF line space spaceON Active Can ® line space spaceOFF Therapies: AT, AF line space spaceOFF Intervention: AT, AF CRT-D Data P/N M950734A001 B SHELF BOX LABEL STERILE PACK LABEL END LABEL 1 END LABEL 2 Trigger Data Viva™ S CRT-D DTBB2D1 DDE-DDDR M950713A001 A - M950734A001 B Adaptive DDD Upper tracking rate and lower rate 130 min -1 50 min -1 line space Sensitivity: RA space0.3 mV line space Sensitivity: RV space0.3 mV line space A-V interval (paced and sensed) 130 ms100 ms line space Amplitude and pulse width: RA 3.5 V } 0.4 ms } line space Amplitude and pulse width: RV 3.5 V } 0.4 ms } line space Amplitude and pulse width: LV 4.0 V } 0.4 ms line space Pace polarity: LV spaceLVtip / RVcoil line space V pacing and V-V pace delay LV->RV0 ms line space Detection: VT, FVT, VF spaceOFF CRT-D YYYY-MM-DD 2000-00-00 WWW000000W 2000-00 YYYY-MM Medtronic, Inc., 710 Medtronic ParkwayMinneapolis, MN 55432 USA Manufactured in:Juncos, Puerto Rico, USA www.medtronic.com Radio compliance FCC ID: LF5MICSIMPLANT3IC: 3408D-MIMPLANT3 N13571Z813 Defibrillation AV cardioversion Burst: RV, LV Burst+: RA Ramp: RA, RV, LV Ramp+: RV, LV 50 Hz Burst: RA Therapies (RV): VT, FVT spaceOFF line space Therapies (delivered and stored): VF space35/42 J line space Active Can ® spaceON line space Therapies: AT, AF spaceOFF line space Intervention: AT, AF spaceOFF Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D DTBB2D1 Implantation date: 2000-00-00 YYYY-MM-DD DTBB2D1 WWW000000W Viva™ S CRT-D DTBB2D1 Implantation date: WWW000000W 2000-00-00 YYYY-MM-DD PIN:W000WWW00W MatrixID:9876543210 PrinterName:MV_PL_HP5550_01 Quantityoflabels:0 TemplateNumber:M950713A001_a DocumentNumber: M950734A DocumentRevision: B UPNUCC:00000000000000 UBD:20000000 ManufactureDate:200000 LotSerial:S LotSerialNumber:WWW000000W ProductNumber:DTBB2D1 AddressCode:007 QualificationStatus: 90 BusinessUnit:MBR M950713A001 A CardioSync™ Optimization PhysioCurve™ Design OptiVol ® 2.0 Fluid Status Monitoring SmartShock™ Technology WWW000000W 2000-00-00 YYYY-MM-DD M950713A001 A - M950734A001 B DTBB2D1 PIN: W000WWW00W Viva™ S CRT-D DTBB2D1 M950713A001 A - M950734A001 B Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D WWW000000W Medtronic DTBB2D1 Viva™ S CRT-D DTBB2D1 Implantation date: WWW000000W 2000-00-00 YYYY-MM-DD Template P/N WWW000000W 2000-00-00 YYYY-MM-DD M950713A001 A - M950734A001 B (01)00000000000000(17)000000(21)WWW000000W DTBB2D1 Viva™ S CRT-D…

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RADIO REGULATORY COMPLIANCE INFORMATION For devices supporting wireless telemetry FCC Compliance Information (FCC ID: LF5MICSIMPLANT3): The following provision applies to the low frequency communications system in the device: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. The user is cautioned that changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. The following provision applies to the UHF communications system in the device: This transmitter is authorized by rule under the Medical Device Radiocommunication Service (in part 95 of the FCC Rules) and must not cause harmful interference to stations operating in the 400.150–406.000 MHz band in the Meteorological Aids (i.e., transmitters and receivers used to communicate weather data), the Meteorological Satellite, or the Earth Exploration Satellite Services and must accept interference that may be caused by such stations, including interference that may cause undesired operation. This transmitter shall be used only in accordance with the FCC Rules governing the Medical Device Radiocommunication Service. Analog and digital voice communications are prohibited. Although this transmitter has been approved by the Federal Communications Commission, there is no guarantee that it will not receive interference or that any particular transmission from this transmitter will be free from interference. The following statement applies to the wireless receiver within the device: This device complies with part 15 of the FCC Rules. Operation is subject to the condition that this device does not cause harmful interference. Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician. *M941895A001* © Medtronic, Inc. 2012 M941895A001A 2012-02-27 World Headquarters Medtronic, Inc. 710 Medtronic Parkway Minneapolis, MN 55432-5604 USA www.medtronic.com Tel. +1-763-514-4000 Fax +1-763-514-4879 Medtronic USA, Inc. Toll-free in the USA (24-hour technical consultation for physicians and medical professionals) Bradycardia: 1-800-505-4636 Tachycardia: 1-800-723-4636 Europe/Africa/Middle East Headquarters Medtronic International Trading Sàrl Route du Molliau 31 Case Postale 84 CH-1131 Tolochenaz Switzerland www.medtronic.com Tel. +41-21-802-7000 Fax +41-21-802-7900 Medtronic E.C. Authorized Representative Medtronic B.V. Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel. +31-45-566-8000 Fax +31-45-566-8668 Technical manuals: www.medtronic.com/manuals

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