Class 2 Device Recall Percepta CRTP MRI SureScan

• Date Initiated by Firm: June 21, 2018
• Date Posted: July 10, 2018
• Recall Status: Terminated on August 19, 2020
• Recall Number: Z-2414-2018
• Recall Event ID: 80433
• PMA Number: P010015
• Product Classification: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
• Product: Percepta CRT-P MRI SureScan, REF W1TR04; ; Product Usage:; The CRT-P models are implantable pulse generators with cardiac resynchronization therapy (CRT-P). These devices monitor and regulate the patient s heart rate by providing single or dual chamber rate responsive bradycardia pacing, sequential biventricular pacing, and atrial tachyarrhythmia therapies. These devices are indicated for heart failure patients who may have atrial arrhythmias or AV block.
• Code Information: GTIN/UPN: (a) 00643169735699 Serial Numbers: RNU601594S RNU601595S RNU601596S RNU601115S RNU601438S RNU601430S RNU600949S RNU600950S RNU601300S RNU601302S RNU601451S RNU601453S RNU600517S RNU600582S RNU600629S RNU600664S RNU600665S RNU600666S RNU600684S RNU600735S RNU600736S RNU600737S RNU600738S RNU600739S RNU600740S RNU600741S RNU600742S RNU600743S RNU600744S RNU600746S RNU600747S RNU600997S RNU601014S RNU601503S RNU601575S RNU601577S RNU601640S RNU601641S RNU601642S RNU601643S RNU601644S RNU601645S RNU601646S RNU601647S RNU601648S RNU601649S RNU601650S RNU601651S RNU601652S RNU601653S RNU601654S RNU601655S RNU601656S RNU601657S RNU601658S RNU601659S RNU601660S RNU601661S RNU601662S RNU601663S RNU601664S RNU601665S RNU601666S RNU601667S RNU601668S RNU601669S RNU601670S RNU601671S RNU601672S RNU601673S RNU601674S RNU601675S RNU601676S RNU601678S RNU601679S RNU601680S RNU601681S RNU601682S RNU601683S RNU601684S RNU601685S RNU601686S RNU601687S RNU601688S RNU601689S RNU601691S RNU601692S RNU601693S RNU601694S RNU601695S RNU601696S RNU601697S RNU601698S RNU601699S RNU601700S RNU601701S RNU601702S RNU601703S RNU601704S RNU601705S RNU601708S RNU601709S RNU601711S RNU601712S RNU601713S RNU601714S RNU601716S RNU601717S RNU601719S RNU601720S RNU601723S RNU601724S RNU601726S RNU601727S RNU601729S RNU601731S RNU601732S RNU601733S RNU601734S RNU601735S RNU601736S RNU601738S RNU601739S RNU601740S RNU601741S RNU601743S RNU601753S RNU601754S RNU601755S RNU601756S RNU601757S RNU601758S RNU601759S RNU601760S RNU601761S RNU601762S RNU601763S RNU601764S RNU601765S RNU601766S RNU601767S RNU601768S RNU601769S RNU601770S RNU601771S RNU601772S RNU601773S RNU601774S RNU601775S RNU601776S RNU601777S RNU601778S RNU601780S RNU601781S RNU601783S RNU601782S RNU601439S RNU601440S RNU601441S RNU601442S RNU601443S RNU601444S RNU601445S RNU601446S RNU601447S RNU601448S RNU601449S RNU601457S RNU601458S RNU601459S RNU601460S RNU601461S RNU601462S RNU601463S RNU600715S RNU600722S RNU600732S RNU600886S RNU601261S RNU601557S RNU601558S RNU601561S RNU601573S RNU601576S RNU601677S RNU601690S RNU601706S RNU601710S RNU601715S RNU601718S RNU601721S RNU601722S RNU601725S RNU601728S RNU601730S RNU601737S RNU601742S RNU601744S RNU601745S RNU601746S RNU601747S RNU601748S RNU601749S RNU601750S RNU601751S RNU601752S RNU601779S RNU601112S RNU601124S RNU600430S RNU601047S RNU601049S RNU601366S RNU601496S RNU600508S RNU600580S RNU601416S RNU600572S RNU601218S RNU601616S RNU601454S RNU600761S RNU600998S RNU601267S RNU601427S RNU600784S RNU600870S RNU601347S RNU600659S RNU601348S RNU601091S RNU600540S RNU600553S RNU601278S RNU601138S RNU601437S RNU600442S RNU601202S RNU601253S RNU600502S RNU601371S RNU601113S RNU600941S RNU601254S RNU600994S RNU601622S RNU601320S RNU600663S RNU601071S RNU601636S RNU600503S RNU600386S RNU601072S RNU600916S RNU601119S RNU601530S RNU601551S RNU600376S RNU600382S RNU601455S RNU600542S RNU601149S RNU601362S RNU601186S RNU601587S RNU601391S RNU601605S RNU600927S RNU601133S RNU600370S RNU601131S RNU601315S RNU601100S RNU600654S RNU600406S RNU601226S RNU601160S RNU601161S RNU600680S RNU600745S RNU601171S RNU600823S RNU601550S RNU600428S RNU600826S RNU601309S RNU601059S RNU601337S RNU601338S RNU601213S RNU600931S RNU600560S RNU600798S RNU601336S RNU600614S RNU600660S RNU600768S RNU601193S RNU601294S RNU601501S RNU601415S RNU601600S RNU600855S RNU600905S RNU600525S RNU601375S RNU600385S RNU601096S RNU600822S RNU601103S RNU601132S RNU600383S RNU600633S RNU601073S RNU600600S RNU600609S RNU601007S RNU601008S RNU601574S RNU600753S RNU600828S RNU600829S RNU600831S RNU601025S RNU601041S RNU601058S RNU601067S RNU601077S RNU601078S RNU601116S RNU601257S RNU601304S RNU601363S RNU601380S RNU601382S RNU601395S RNU601417S RNU601477S RNU601481S RNU601502S RNU601510S RNU601537S RNU601586S RNU600509S RNU600667S RNU600841S RNU600902S RNU601397S RNU601489S RNU600399S RNU600394S RNU600904S RNU600933S RNU600934S RNU601384S RNU600917S RNU601095S RNU600257S RNU600258S RNU600259S RNU600371S RNU600749S RNU600751S RNU600918S RNU600921S RNU600928S RNU600930S RNU601285S RNU601287S RNU601385S RNU601388S RNU601399S RNU601464S RNU601467S RNU601512S RNU600374S RNU600384S RNU600754S RNU600820S RNU600821S RNU600825S RNU600926S RNU600939S RNU601102S RNU601342S RNU600915S RNU601352S RNU600972S RNU600635S RNU600636S RNU600637S RNU600638S RNU601121S RNU601584S RNU601074S RNU601075S RNU600796S RNU600797S RNU601027S RNU601028S RNU601030S RNU601469S RNU601470S RNU601471S RNU601472S RNU601474S RNU600369S RNU600506S RNU600670S RNU600675S RNU600901S RNU600952S RNU600954S RNU601065S RNU601167S RNU601168S RNU601169S RNU601242S RNU601243S RNU601349S RNU601431S RNU601433S RNU601475S RNU601629S RNU601162S RNU601163S RNU601181S RNU601376S RNU601386S RNU601413S RNU601466S RNU601597S RNU601495S RNU601505S RNU601506S RNU600451S RNU601331S RNU601340S RNU601478S RNU601566S RNU601580S RNU601581S RNU600357S RNU600983S RNU601069S RNU601248S RNU601619S RNU600647S RNU600414S RNU600437S RNU600439S RNU600441S RNU600679S RNU600996S RNU601122S RNU601343S RNU601542S RNU600837S RNU600416S RNU600469S RNU600488S RNU600964S RNU600606S RNU601063S RNU601493S RNU601520S RNU600965S RNU601406S RNU601005S RNU601006S RNU600527S RNU600871S RNU600487S RNU601020S RNU601099S RNU600640S RNU600641S RNU600642S RNU601093S RNU601204S RNU600604S RNU600879S RNU601114S RNU601327S RNU601328S RNU601544S RNU601553S RNU600413S RNU600446S RNU601217S RNU601321S RNU600607S RNU600615S RNU600946S RNU600947S RNU601089S RNU601239S RNU600975S RNU600976S RNU601292S RNU601504S RNU601003S RNU601004S RNU601034S RNU601079S RNU601220S RNU601488S RNU600350S RNU600605S RNU600639S RNU601106S RNU600824S RNU600395S RNU600398S RNU600465S RNU600459S RNU600477S RNU600811S RNU601019S RNU601536S RNU600373S RNU600621S RNU600358S RNU600598S RNU600834S RNU601088S RNU601118S RNU601365S RNU601434S RNU600489S RNU601037S RNU601039S RNU600625S RNU600856S RNU600624S RNU600671S RNU600839S RNU601087S RNU601554S RNU601559S RNU601499S RNU601516S RNU601626S RNU601070S RNU601545S RNU601549S RNU601083S RNU601084S RNU601134S RNU601137S RNU600452S RNU600453S RNU600457S RNU601188S RNU601378S RNU600407S RNU600408S RNU600409S RNU600867S RNU600868S RNU600869S RNU600363S RNU600364S RNU600900S RNU601353S RNU600706S RNU601000S RNU601001S RNU601543S RNU600772S RNU601024S RNU600410S RNU600496S RNU600534S RNU600535S RNU600576S RNU600577S RNU600578S RNU600789S RNU600986S RNU600987S RNU601050S RNU601051S RNU601398S RNU601400S RNU601401S RNU601402S RNU600405S RNU600802S RNU600857S RNU600864S RNU601009S RNU601081S RNU601156S RNU601157S RNU601227S RNU601228S RNU601351S RNU601101S RNU601281S RNU600393S RNU600914S RNU600922S RNU600923S RNU601283S RNU601318S RNU601428S RNU600948S RNU601262S RNU601270S RNU601271S RNU601301S RNU601311S RNU601372S RNU601374S RNU601425S RNU600519S RNU600697S RNU600793S RNU601064S RNU601110S RNU601275S RNU600429S RNU601295S RNU600568S RNU600955S RNU600966S RNU600551S RNU601056S RNU600550S RNU600433S RNU600847S RNU600549S RNU600844S RNU600445S RNU600860S RNU600536S RNU600537S RNU600379S RNU600390S RNU600945S RNU601040S RNU600688S RNU600381S RNU601128S RNU601043S RNU601044S RNU601052S RNU600421S RNU601076S RNU601053S RNU600539S RNU600541S RNU600967S RNU601042S RNU600377S RNU601146S RNU600944S RNU600500S RNU600380S RNU600853S RNU601033S RNU601251S RNU601141S RNU601256S RNU601308S RNU601164S RNU600758S RNU601325S RNU600464S RNU601011S RNU601013S RNU600969S RNU600396S RNU600412S RNU601393S RNU601233S RNU601299S RNU601479S RNU600882S RNU601264S RNU601263S RNU601373S RNU600653S RNU601319S RNU600898S RNU600734S RNU600891S RNU600892S RNU601272S RNU601364S RNU601368S RNU601556S RNU600391S RNU600650S RNU600651S RNU600652S RNU600676S RNU600708S RNU600709S RNU600710S RNU600712S RNU600713S RNU600714S RNU600716S RNU600717S RNU600718S RNU600719S RNU600720S RNU600721S RNU600723S RNU600724S RNU600725S RNU600726S RNU600727S RNU600728S RNU600729S RNU600730S RNU600731S RNU600733S RNU600881S RNU600883S 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RNU600530S RNU601191S RNU600617S RNU600618S RNU600698S RNU601249S RNU600498S RNU601633S RNU600461S RNU601126S RNU601266S RNU601358S RNU600555S RNU600353S RNU600803S RNU601216S RNU600610S RNU600612S RNU600748S RNU601607S RNU601637S RNU600704S RNU600799S RNU600981S RNU600990S RNU600570S RNU600571S RNU600850S RNU601407S RNU600586S RNU601054S RNU600440S RNU600622S RNU600788S RNU601540S RNU600522S RNU600643S RNU600925S RNU601189S RNU601190S RNU601222S RNU600878S RNU601565S RNU601625S RNU600468S RNU600543S RNU600833S RNU601166S RNU600631S RNU600669S RNU601158S RNU601590S RNU601591S RNU601592S RNU600705S RNU601123S RNU601184S RNU601312S RNU601330S RNU600672S RNU600683S RNU601568S RNU601602S RNU600526S RNU601396S RNU600544S RNU600884S RNU601021S RNU601023S RNU600655S RNU600677S RNU600771S RNU600911S RNU601215S RNU601579S RNU600682S RNU600859S RNU601170S RNU601296S RNU601509S RNU601225S RNU601624S RNU600932S RNU600403S RNU600404S RNU601245S RNU601514S RNU600483S RNU600484S RNU600852S RNU600920S 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RNU600546S RNU600830S RNU600861S RNU601143S RNU601610S RNU601199S RNU601200S RNU601208S RNU601209S RNU601324S RNU600375S RNU601314S RNU601483S RNU601484S RNU601485S RNU601486S RNU601487S RNU601117S RNU601120S RNU600574S RNU601172S RNU601173S RNU601174S RNU601175S RNU601176S RNU601230S RNU601231S RNU601232S RNU601234S RNU601235S RNU601236S RNU601237S RNU601238S RNU601521S RNU601522S RNU601523S RNU601524S RNU601526S RNU600575S RNU600648S RNU601061S RNU600561S RNU600562S RNU600792S RNU600907S RNU600770S RNU600809S RNU600810S RNU600427S RNU600800S RNU600603S RNU601585S RNU600563S RNU601082S RNU601538S RNU601539S RNU601221S RNU601334S RNU601155S RNU601031S RNU600372S RNU600449S RNU600450S RNU600874S RNU600875S RNU600876S RNU600877S RNU601418S RNU601419S RNU601420S RNU601423S RNU601424S RNU601426S RNU600854S RNU600832S RNU601303S RNU600507S RNU600980S RNU601276S RNU601277S RNU601279S RNU600387S RNU600426S RNU600940S RNU600402S RNU600454S RNU600455S RNU600456S RNU600512S RNU600366S RNU601268S RNU601255S RNU601564S RNU600552S RNU600556S RNU600956S RNU600957S RNU600958S RNU600959S RNU600962S RNU600963S RNU600419S RNU600899S RNU601613S RNU601614S RNU601615S RNU600913S RNU600968S RNU600838S RNU601029S RNU601060S RNU600596S RNU600581S RNU600415S RNU601326S RNU601062S RNU601291S RNU600516S RNU601085S RNU601632S RNU600814S RNU600365S RNU600417S RNU600943S RNU601241S RNU601244S RNU601323S RNU600662S RNU600924S RNU600836S RNU600778S RNU600779S RNU601508S RNU601603S RNU600644S RNU601310S RNU601356S RNU600515S RNU600767S RNU600794S RNU601130S RNU601412S RNU601627S RNU600480S RNU600566S RNU600634S RNU600686S RNU600763S RNU600764S RNU600791S RNU600858S RNU600910S RNU601214S RNU601355S RNU601403S RNU601404S RNU601450S RNU601562S RNU601563S RNU601571S RNU601578S RNU601630S RNU600462S RNU600463S RNU600750S RNU600863S RNU600993S RNU601313S RNU601480S RNU601518S RNU601129S RNU601207S RNU601335S RNU600400S RNU600435S RNU601593S RNU600804S RNU600805S RNU601017S RNU601205S RNU601306S RNU601332S RNU601333S RNU601623S RNU600759S RNU600760S RNU600880S RNU601127S RNU600773S RNU600482S RNU600620S RNU600475S RNU600476S RNU600587S RNU600613S RNU600777S RNU600807S RNU601179S RNU600776S RNU600783S RNU601606S RNU600873S RNU600547S RNU601541S RNU601022S RNU601247S RNU600573S RNU600819S RNU601046S RNU600466S RNU600623S RNU601105S RNU601284S RNU601286S RNU601322S RNU601414S RNU601492S RNU601567S RNU601097S RNU600401S RNU600816S RNU601604S RNU601635S RNU601639S RNU600591S RNU600978S RNU600991S RNU600848S RNU600903S RNU600960S RNU600977S RNU601490S RNU601511S RNU600628S RNU601048S RNU601147S RNU601240S RNU601182S RNU601476S RNU601494S RNU601570S RNU600523S RNU600524S RNU601177S RNU601178S RNU600584S RNU600585S RNU600590S RNU600592S RNU600593S RNU600692S RNU600693S RNU600694S RNU600699S RNU600707S RNU601210S RNU601211S RNU601223S RNU601224S RNU601288S RNU601289S RNU601290S RNU601344S RNU601345S RNU601346S RNU601527S RNU601528S RNU601529S RNU601531S RNU601532S RNU601357S RNU601497S RNU601546S RNU601432S RNU600388S RNU600431S RNU600436S RNU600438S RNU600444S RNU601125S RNU601148S RNU600351S RNU601185S RNU601383S RNU601435S RNU600846S RNU600849S RNU601452S RNU601601S RNU601507S RNU601611S RNU600673S RNU600775S RNU601421S RNU601547S RNU601548S RNU600434S RNU601515S RNU601631S RNU601638S RNU601354S RNU601589S RNU600608S RNU600611S RNU600681S RNU601429S RNU600514S RNU600627S RNU600678S RNU601057S RNU600378S RNU601198S RNU601468S RNU601409S RNU601410S RNU601018S RNU601297S RNU601341S RNU600938S RNU601369S RNU601144S RNU601145S RNU600815S (b)00643169891524 Serial Numbers: RNU600795S RNU600146S RNU600274S RNU600219S RNU600183S RNU600307S RNU600308S RNU600262S RNU600260S RNU600209S RNU600271S RNU600152S RNU600181S RNU600156S RNU600188S RNU600213S RNU600231S RNU600234S RNU600177S RNU600207S RNU600268S RNU600164S RNU600267S RNU600151S RNU600187S RNU600264S RNU600208S RNU600221S RNU600330S RNU600159S RNU600215S RNU600226S RNU600246S RNU600247S RNU600249S RNU600255S RNU600287S RNU600291S RNU600293S RNU600176S RNU600163S RNU600180S RNU600182S RNU600193S RNU600200S RNU600201S RNU600202S RNU600203S RNU600321S RNU600204S RNU600256S RNU600161S RNU600314S RNU600220S RNU600325S RNU600195S RNU600302S RNU600296S RNU600297S RNU600300S RNU600216S RNU600233S RNU600339S RNU600172S RNU600185S RNU600170S RNU600301S RNU600206S RNU600322S RNU600323S RNU600327S RNU600328S RNU600251S RNU600160S RNU600178S RNU600148S RNU600153S RNU600199S RNU600275S RNU600310S RNU600143S RNU600191S RNU600174S RNU600266S RNU600141S RNU600189S RNU600190S RNU600248S RNU600320S RNU600346S RNU600210S RNU600303S RNU600230S RNU600290S RNU600280S RNU600292S RNU600284S RNU600228S RNU600229S RNU600286S RNU600225S RNU600243S RNU600261S RNU600338S RNU600239S RNU600341S RNU600175S RNU600150S RNU600318S RNU600250S RNU600285S RNU600238S RNU600145S RNU600347S RNU600212S RNU600299S RNU600324S RNU600154S RNU600166S RNU600272S RNU600332S RNU600222S RNU600265S RNU600333S RNU600334S RNU600196S RNU600227S RNU600167S RNU600315S RNU600269S RNU600157S RNU600236S RNU600313S RNU600149S RNU600197S RNU600198S RNU600273S RNU600312S RNU600194S RNU600335S RNU600336S RNU600277S RNU600237S RNU600245S RNU600279S RNU600281S RNU600240S RNU600253S RNU600309S RNU600317S RNU600276S RNU600278S RNU600184S RNU600298S RNU600306S RNU600311S RNU600168S RNU600169S RNU600305S RNU600304S RNU600345S RNU600205S RNU600232S RNU600295S RNU600337S RNU600348S RNU600270S RNU600244S RNU600329S RNU600179S RNU600158S RNU600214S RNU600254S RNU600294S RNU600316S RNU600342S RNU600242S RNU600252S RNU600218S RNU600173S RNU600319S RNU600326S RNU600331S RNU600192S RNU600186S RNU600263S RNU600165S RNU600344S RNU600147S RNU600288S RNU600289S RNU600241S RNU600282S RNU600224S RNU600235S
• Recalling Firm/ Manufacturer: Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF); 8200 Coral Sea St Ne; Mounds View MN 55112-4391
• For Additional Information Contact: Medtronic Technical Services; 800-723-4636
• Manufacturer Reason for Recall: Potential for a device reset to occur in Percepta CRT-P MRI SureScan and Percepta Quad CRT-P MRI SureScan due to a timing interaction between the EffectivCRT Diagnostic and the Ventricular Safety Pacing feature (VSP).
• FDA Determined Cause: Device Design
• Action: On 21-Jun-2018, Medtronic began notifying US physicians and health care professionals of this issue and provided Patient Management recommendations to ensure patient safety. A Software Update to SW040 Version 8.1 will be deployed to all Medtronic 2090 and Encore clinic and hospital programmers via the Software Distribution Network or USB. Field Representatives with customers who have Percepta CRT-P patients will be sent a USB device loaded with the updated software. In consultation with an Independent Physician Quality Panel, Medtronic recommends the following actions for physicians following patients: - Contact your local Medtronic Representative and schedule installation of the updated Percepta CRT-P Application Software (SW040 Version 8.1) onto Medtronic 2090 and Encore clinic and hospital programmers. - For a patient whose Percepta CRT-P device has experienced a Reset Alert or Observation: Consider scheduling an in-clinic device interrogation as soon as possible for the patients device to receive the automatic update. - For a patient whose Percepta CRT-P device has not experienced a Reset Alert or Observation: At their next scheduled in-clinic device interrogation, the patients device will receive the automatic update. Please complete the enclosed Clinician Confirmation Certificate and return via email to RS.CFQFCA@medtronic.com. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.
• Quantity in Commerce: 1604 units
• Distribution: Worldwide Distribution - US Nationwide
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = NKE and Original Applicant = MEDTRONIC Inc.