Class 2 Device Recall Kinetra Implantable Neurostimulator

• Date Initiated by Firm: October 01, 2007
• Date Posted: February 05, 2008
• Recall Status: Terminated on May 03, 2012
• Recall Number: Z-0693-2008
• Recall Event ID: 45847
• Product Classification: Neurostimulator - Product Code MHY
• Product: Medtronic Kinetra 7428, Dual Program Neurostimulator for Deep Brain Stimulation, Rx only, Medtronic, Inc., Minneapolis, MN 55432-5604 USA. (The Medtronic Kinetra Model 7428 Neurostimulator is a multiprogrammable device and a component of the Kinetra Neurostimulator System for deep brain stimulation.)
• Code Information: NFD100921H, NFD100922H, NFD100924H, NFD100925H, NFD100926H, NFD100928H, NFD100930H, NFD100931H, NFD100932H, NFD100939H, NFD100940H, NFD100941H, NFD100943H, NFD100944H, NFD100945H, NFD100946H, NFD100947H, NFD100948H, NFD100949H, NFD100950H, NFD100951H, NFD100952H, NFD100960H, NFD100961H, NFD100963H, NFD100964H, NFD100965H, NFD100966H, NFD100967H, NFD100968H, NFD100969H, NFD100970H, NFD100971H, NFD100974H, NFD100978H, NFD100980H, NFD100982H, NFD100983H, NFD100985H, NFD100986H, NFD100996H, NFD100997H, NFD100998H, NFD100999H, NFD101000H, NFD101002H, NFD101003H, NFD101005H, NFD101006H, NFD101007H, NFD101008H, NFD101009H, NFD101010H, NFD101011H, NFD101012H, NFD101013H, NFD101014H, NFD101015H, NFD101017H, NFD101018H, NFD101020H, NFD101021H, NFD101023H, NFD101024H, NFD101025H, NFD101026H, NFD101027H, NFD101028H, NFD101030H, NFD101031H, NFD101033H, NFD101035H, NFD101036H, NFD101037H, NFD101038H, NFD101040H, NFD101041H, NFD101042H, NFD101043H, NFD101044H, NFD101045H, NFD101046H, NFD101047H, NFD101048H, NFD101049H, NFD101050H, NFD101051H, NFD101053H, NFD101055H, NFD101056H, NFD101057H, NFD101058H, NFD101060H, NFD101061H, NFD101062H, NFD101064H, NFD101066H, NFD101070H, NFD101073H, NFD101075H, NFD101076H, NFD101077H, NFD101078H, NFD101079H, NFD101080H, NFD101081H, NFD101082H, NFD101085H, NFD101087H, NFD101088H, NFD101089H, NFD101090H, NFD101092H, NFD101093H, NFD101094H, NFD101095H, NFD101096H, NFD101097H, NFD101098H, NFD101099H, NFD101100H, NFD101101H, NFD101102H, NFD101103H, NFD101104H, NFD101105H, NFD101106H, NFD101110H, NFD101132H, NFD101136H, NFD101140H, NFD101141H, NFD101146H, NFD101237H, NFD101243H, NFD101248H, NFD101249H, NFD621879S, NFD621880S, NFD621882S, NFD621883S, NFD621884S, NFD621885S, NFD621886S, NFD621887S, NFD621888S, NFD621889S, NFD621891S, NFD621892S, NFD621893S, NFD621895S, NFD621896S, NFD621897S, NFD621898S, NFD621900S, NFD621901S, NFD621902S, NFD621903S, NFD621904S, NFD621905S, NFD621906S, NFD621908S, NFD621910S, NFD621911S, NFD621912S, NFD621914S, NFD621915S, NFD621916S, NFD621917S, NFD621918S, NFD621919S, NFD621920S, NFD621921S, NFD621922S, NFD621923S, NFD621924S, NFD621925S, NFD621926S, NFD621927S, NFD621928S, NFD621929S, NFD621931S, NFD621932S, NFD621933S, NFD621934S, NFD621935S, NFD621936S, NFD621937S, NFD621938S, NFD621939S, NFD621940S, NFD621941S, NFD621943S, NFD621949S, NFD621951S, NFD621953S, NFD621958S, NFD621963S, NFD621964S, NFD621968S, NFD621979S, NFD621981S, NFD621982S, NFD621989S, NFD621991S, NFD621992S, NFD621995S, NFD622004S, NFD622005S, NFD622008S, NFD622011S, NFD622013S, NFD622014S, NFD622015S, NFD622016S, NFD622019S, NFD622020S, NFD622023S, NFD622024S, NFD622026S, NFD622027S, NFD622029S, NFD622030S, NFD622031S, NFD622033S, NFD622035S, NFD622037S, NFD622038S, NFD622039S, NFD622040S, NFD622041S, NFD622043S, NFD622046S, NFD622048S, NFD622049S, NFD622050S, NFD622051S, NFD622052S, NFD622053S, NFD622054S, NFD622055S, NFD622056S, NFD622057S, NFD622058S, NFD622059S, NFD622060S, NFD622061S, NFD622062S, NFD622063S, NFD622064S, NFD622065S, NFD622066S, NFD622067S, NFD622068S, NFD622069S, NFD622071S, NFD622073S, NFD622074S, NFD622075S, NFD622076S, NFD622077S, NFD622078S, NFD622079S, NFD622080S, NFD622081S, NFD622082S, NFD622083S, NFD622084S, NFD622085S, NFD622086S, NFD622090S, NFD622092S, NFD622093S, NFD622094S, NFD622095S, NFD622096S, NFD622098S, NFD622099S, NFD622101S, NFD622102S, NFD622103S, NFD622104S, NFD622105S, NFD622107S, NFD622108S, NFD622109S, NFD622110S, NFD622111S, NFD622112S, NFD622113S, NFD622114S, NFD622115S, NFD622116S, NFD622117S, NFD622118S, NFD622119S, NFD622120S, NFD622121S, NFD622122S, NFD622123S, NFD622125S, NFD622126S, NFD622127S, NFD622128S, NFD622129S, NFD622130S, NFD622131S, NFD622132S, NFD622133S, NFD622134S, NFD622135S, NFD622136S, NFD622137S, NFD622138S, NFD622139S, NFD622142S, NFD622143S, NFD622145S, NFD622147S, NFD622148S, NFD622149S, NFD622150S, NFD622151S, NFD622152S, NFD622153S, NFD622154S, NFD622156S, NFD622157S, NFD622159S, NFD622161S, NFD622162S, NFD622163S, NFD622164S, NFD622165S, NFD622166S, NFD622167S, NFD622168S, NFD622169S, NFD622171S, NFD622173S, NFD622174S, NFD622175S, NFD622176S, NFD622178S, NFD622180S, NFD622181S, NFD622182S, NFD622183S, NFD622184S, NFD622185S, NFD622186S, NFD622188S, NFD622189S, NFD622190S, NFD622191S, NFD622194S, NFD622195S, NFD622196S, NFD622197S, NFD622198S, NFD622199S, NFD622200S, NFD622201S, NFD622202S, NFD622203S, NFD622205S, NFD622206S, NFD622207S, NFD622208S, NFD622209S, NFD622211S, NFD622212S, NFD622213S, NFD622215S, NFD622216S, NFD622218S, NFD622221S, NFD622222S, NFD622223S, NFD622224S, NFD622226S, NFD622227S, NFD622228S, NFD622229S, NFD622230S, NFD622231S, NFD622232S, NFD622233S, NFD622234S, NFD622236S, NFD622237S, NFD622238S, NFD622239S, NFD622242S, NFD622243S, NFD622244S, NFD622245S, NFD622246S, NFD622247S, NFD622248S, NFD622249S, NFD622250S, NFD622251S, NFD622252S, NFD622253S, NFD622254S, NFD622255S, NFD622257S, NFD622258S, NFD622259S, NFD622260S, NFD622261S, NFD622262S, NFD622263S, NFD622264S, NFD622265S, NFD622266S, NFD622268S, NFD622269S, NFD622270S, NFD622271S, NFD622272S, NFD622273S, NFD622275S, NFD622276S, NFD622277S, NFD622278S, NFD622279S, NFD622280S, NFD622281S, NFD622282S, NFD622283S, NFD622284S, NFD622285S, NFD622286S, NFD622287S, NFD622288S, NFD622289S, NFD622290S, NFD622291S, NFD622292S, NFD622293S, NFD622294S, NFD622295S, NFD622296S, NFD622297S, NFD622298S, NFD622299S, NFD622300S, NFD622301S, NFD622302S, NFD622303S, NFD622304S, NFD622305S, NFD622306S, NFD622307S, NFD622308S, NFD622309S, NFD622310S, NFD622312S, NFD622313S, NFD622315S, NFD622316S, NFD622317S, NFD622318S, NFD622320S, NFD622321S, NFD622322S, NFD622323S, NFD622324S, NFD622325S, NFD622326S, NFD622327S, NFD622328S, NFD622329S, NFD622330S, NFD622331S, NFD622333S, NFD622334S, NFD622335S, NFD622337S, NFD622340S, NFD622342S, NFD622343S, NFD622344S, NFD622345S, NFD622346S, NFD622347S, NFD622348S, NFD622349S, NFD622351S, NFD622352S, NFD622353S, NFD622354S, NFD622355S, NFD622356S, NFD622357S, NFD622358S, NFD622359S, NFD622360S, NFD622361S, NFD622362S, NFD622363S, NFD622364S, NFD622365S, NFD622366S, NFD622370S, NFD622371S, NFD622372S, NFD622373S, NFD622374S, NFD622375S, NFD622376S, NFD622377S, NFD622378S, NFD622379S, NFD622380S, NFD622381S, NFD622382S, NFD622383S, NFD622384S, NFD622385S, NFD622386S, NFD622387S, NFD622388S, NFD622389S, NFD622390S, NFD622391S, NFD622392S, NFD622394S, NFD622396S, NFD622397S, NFD622398S, NFD622399S, NFD622400S, NFD622401S, NFD622402S, NFD622403S, NFD622404S, NFD622405S, NFD622406S, NFD622407S, NFD622408S, NFD622409S, NFD622410S, NFD622411S, NFD622412S, NFD622413S, NFD622414S, NFD622415S, NFD622416S, NFD622417S, NFD622418S, NFD622419S, NFD622420S, NFD622421S, NFD622423S, NFD622424S, NFD622425S, NFD622427S, NFD622428S, NFD622429S, NFD622430S, NFD622431S, NFD622432S, NFD622433S, NFD622434S, NFD622435S, NFD622436S, NFD622437S, NFD622438S, NFD622439S, NFD622440S, NFD622441S, NFD622442S, NFD622443S, NFD622444S, NFD622445S, NFD622446S, NFD622448S, NFD622449S, NFD622450S, NFD622451S, NFD622452S, NFD622453S, NFD622457S, NFD622457S, NFD622458S, NFD622459S, NFD622460S, NFD622462S, NFD622476S, NFD622484S, NFD622488S, NFD622491S, NFD622497S, NFD622498S, NFD622499S, NFD622500S, NFD622501S, NFD622502S, NFD622503S, NFD622504S, NFD622505S, NFD622506S, NFD622507S, NFD622508S, NFD622509S, NFD622510S, NFD622511S, NFD622513S, NFD622514S, NFD622515S, NFD622516S, NFD622517S, NFD622518S, NFD622520S, NFD622521S, NFD622523S, NFD622524S, NFD622525S, NFD622526S, NFD622527S, NFD622528S, NFD622529S, NFD622530S, NFD622531S, NFD622532S, NFD622533S, NFD622534S, NFD622535S, NFD622536S, NFD622537S, NFD622539S, NFD622540S, NFD622541S, NFD622542S, NFD622543S, NFD622544S, NFD622545S, NFD622546S, NFD622547S, NFD622548S, NFD622549S, NFD622550S, NFD622551S, NFD622555S, NFD622556S, NFD622557S, NFD622558S, NFD622559S, NFD622560S, NFD622562S, NFD622563S, NFD622564S, NFD622565S, NFD622566S, NFD622568S, NFD622569S, NFD622570S, NFD622571S, NFD622572S, NFD622573S, NFD622574S, NFD622575S, NFD622577S, NFD622578S, NFD622579S, NFD622580S, NFD622581S, NFD622583S, NFD622584S, NFD622586S, NFD622587S, NFD622588S, NFD622589S, NFD622590S, NFD622591S, NFD622592S, NFD622593S, NFD622594S, NFD622598S, NFD622599S, NFD622602S, NFD622604S, NFD622605S, NFD622606S, NFD622607S, NFD622608S, NFD622610S, NFD622613S, NFD622615S, NFD622616S, NFD622617S, NFD622619S, NFD622620S, NFD622621S, NFD622622S, NFD622624S, NFD622625S, NFD622626S, NFD622627S, NFD622632S, NFD622633S, NFD622634S, NFD622635S, NFD622636S, NFD622638S, NFD622640S, NFD622642S, NFD622643S, NFD622646S, NFD622654S, NFD622659S, NFD622661S, NFD622662S, NFD622663S, NFD622666S, NFD622680S, NFD622682S, NFD622684S, NFD622685S, NFD622686S, NFD622687S, NFD622688S, NFD622689S, NFD622690S, NFD622692S, NFD622693S, NFD622694S, NFD622695S, NFD622697S, NFD622699S, NFD622700S, NFD622701S, NFD622702S, NFD622706S, NFD622716S, NFD622719S, NFD622720S, NFD622721S, NFD622722S, NFD622723S, NFD622727S, NFD622728S, NFD622729S, NFD622732S, NFD622733S, NFD622734S, NFD622742S, NFD622745S, NFD622764S, NFD622782S, NFD622823S, NFD622825S, NFD622826S, NFD622831S, NFD622832S, NFD622839S, NFD622841S, NFD622842S, NFD622844S, NFD622846S, NFD622853S, NFD622855S, NFD622856S, NFD622858S, NFD622859S, NFD622861S, NFD622868S, NFD622871S, NFD622964S, NFD622972S, NFD622978S, NFD622986S, NFD622992S, NFD622994S, NFD622997S, NFD622998S, NFD623021S, NFD623022S, NFD623023S, NFD623038S, NFD623041S, NFD623044S, NFD623045S, NFD623046S, NFD623050S, NFD623053S, NFD623054S, NFD623056S, NFD623061S, NFD623062S, NFD623068S, NFD623081S, NFD623110S, NFD623112S, NFD623118S, NFD623566S, NFD627407S, NFD627418S, NFD627420S, NFD627424S, NFD627425S, NFD627426S, NFD627427S, NFD627428S, NFD627429S, NFD627430S, NFD627431S, NFD627432S, NFD627433S, NFD627435S, NFD627436S, NFD627437S, NFD627439S, NFD627440S, NFD627441S, NFD627442S, NFD627443S, NFD627444S, NFD627445S, NFD627446S, NFD627447S, NFD627448S, NFD627450S, NFD627451S, NFD627452S, NFD627453S, NFD627454S, NFD627455S, NFD627457S, NFD627458S, NFD627459S, NFD627460S, NFD627462S, NFD627463S, NFD627464S, NFD627465S, NFD627466S, NFD627467S, NFD627468S, NFD627469S, NFD627470S, NFD627471S, NFD627472S, NFD627473S, NFD627474S, NFD627475S, NFD627476S, NFD627477S, NFD627478S, NFD627479S, NFD627480S, NFD627481S, NFD627482S, NFD627487S, NFD627491S, NFD627496S, NFD627497S, NFD627498S, NFD627502S, NFD627505S, NFD627507S, NFD627511S, NFD627512S, NFD627516S, NFD627525S, NFD627529S, NFD627532S, NFD627559S, NFD627564S, NFD627565S, NFD627566S, NFD627567S, NFD627568S, NFD627571S, NFD627572S, NFD627573S, NFD627574S, NFD627575S, NFD627576S, NFD627577S, NFD627578S, NFD627579S, NFD627581S, NFD627582S, NFD627583S, NFD627584S, NFD627585S, NFD627586S, NFD627587S, NFD627588S, NFD627589S, NFD627590S, NFD627591S, NFD627592S, NFD627593S, NFD627594S, NFD627595S, NFD627596S, NFD627597S, NFD627598S, NFD627599S, NFD627600S, NFD627601S, NFD627602S, NFD627603S, NFD627604S, NFD627605S, NFD627606S, NFD627607S, NFD627608S, NFD627609S, NFD627610S, NFD627611S, NFD627612S, NFD627614S, NFD627615S, NFD627616S, NFD627617S, NFD627618S, NFD627619S, NFD627620S, NFD627621S, NFD627622S, NFD627624S, NFD627625S, NFD627626S, NFD627627S, NFD627628S, NFD627629S, NFD627630S, NFD627631S, NFD627632S, NFD627633S, NFD627634S, NFD627635S, NFD627636S, NFD627637S, NFD627638S, NFD627639S, NFD627640S, NFD627641S, NFD627642S, NFD627643S, NFD627644S, NFD627645S, NFD627646S, NFD627647S, NFD627648S, NFD627650S, NFD627651S, NFD627652S, NFD627653S, NFD627654S, NFD627655S, NFD627656S, NFD627657S, NFD627658S, NFD627659S, NFD627660S, NFD627661S, NFD627662S, NFD627663S, NFD627664S, NFD627665S, NFD627666S, NFD627667S, NFD627668S, NFD627669S, NFD627670S, NFD627671S, NFD627672S, NFD627673S, NFD627674S, NFD627675S, NFD627676S, NFD627677S, NFD627678S, NFD627679S, NFD627680S, NFD627681S, NFD627682S, NFD627683S, NFD627684S, NFD627685S, NFD627686S, NFD627687S, NFD627688S, NFD627689S, NFD627690S, NFD627691S, NFD627692S, NFD627693S, NFD627694S, NFD627695S, NFD627696S, NFD627697S, NFD627698S.NFD627699S, NFD627700S, NFD627701S, NFD627702S, NFD627703S, NFD627704S, NFD627707S, NFD627708S, NFD627709S, NFD627710S, NFD627711S, NFD627712S, NFD627713S, NFD627714S, NFD627715S, NFD627716S, NFD627717S, NFD627718S, NFD627719S, NFD627720S, NFD627721S, NFD627722S, NFD627723S, NFD627724S, NFD627725S, NFD627726S, NFD627727S, NFD627728S, NFD627729S, NFD627730S, NFD627731S, NFD627732S, NFD627733S, NFD627734S, NFD627735S, NFD627736S, NFD627737S, NFD627738S, NFD627739S, NFD627740S, NFD627741S, NFD627742S, NFD627743S, NFD627744S, NFD627745S, NFD627746S, NFD627747S, NFD627748S, NFD627749S, NFD627750S, NFD627751S, NFD627752S, NFD627753S, NFD627754S, NFD627755S, NFD627756S, NFD627757S, NFD627758S, NFD627759S, NFD627760S, NFD627761S, NFD627762S, NFD627763S, NFD627764S, NFD627765S, NFD627766S, NFD627767S, NFD627768S, NFD627769S, NFD627770S, NFD627771S, NFD627773S, NFD627774S, NFD627775S, NFD627776S, NFD627777S, NFD627778S, NFD627779S, NFD627780S, NFD627781S, NFD627782S, NFD627783S, NFD627784S, NFD627785S, NFD627786S, NFD627787S, NFD627788S, NFD627789S, NFD627790S, NFD627791S, NFD627793S, NFD627794S, NFD627795S, NFD627796S, NFD627797S, NFD627798S, NFD627799S, NFD627800S, NFD627801S, NFD627802S, NFD627803S, NFD627804S, NFD627805S, NFD627806S, NFD627807S, NFD627808S, NFD627809S, NFD627810S, NFD627811S, NFD627812S, NFD627813S, NFD627814S, NFD627815S, NFD627816S, NFD627817S, NFD627818S, NFD627819S, NFD627820S, NFD627821S, NFD627822S, NFD627823S, NFD627824S, NFD627825S, NFD627826S, NFD627827S, NFD627828S, NFD627829S, NFD627830S, NFD627831S, NFD627832S, NFD627833S, NFD627835S, NFD627836S, NFD627837S, NFD627838S, NFD627839S, NFD627840S, NFD627841S, NFD627842S, NFD627843S, NFD627845S, NFD627846S, NFD627847S, NFD627848S, NFD627850S, NFD627851S, NFD627852S, NFD627853S, NFD627854S, NFD627855S, NFD627856S, NFD627857S, NFD627858S, NFD627859S, NFD627860S, NFD627861S, NFD627862S, NFD627863S, NFD627864S, NFD627865S, NFD627866S, NFD627867S, NFD627868S, NFD627869S, NFD627870S, NFD627871S, NFD627872S, NFD627873S, NFD627874S, NFD627875S, NFD627876S, NFD627877S, NFD627878S, NFD627879S, NFD627880S, NFD627881S, NFD627882S, NFD627883S, NFD627884S, NFD627885S, NFD627886S, NFD627887S, NFD627888S, NFD627889S, NFD627890S, NFD627891S, NFD627892S, NFD627893S, NFD627894S, NFD627895S, NFD627896S, NFD627897S, NFD627898S, NFD627899S, NFD627900S, NFD627901S, NFD627902S, NFD627903S, NFD627904S, NFD627905S, NFD627906S, NFD627907S, NFD627908S, NFD627909S, NFD627910S, NFD627911S, NFD627912S, NFD627913S, NFD627914S, NFD627915S, NFD627916S, NFD627917S, NFD627918S, NFD627919S, NFD627920S, NFD627921S, NFD627922S, NFD627923S, NFD627924S, NFD627925S, NFD627926S, NFD627927S, NFD627928S, NFD627929S, NFD627930S, NFD627931S, NFD627932S, NFD627933S, NFD627934S, NFD627935S, NFD627936S, NFD627937S, NFD627938S, NFD627939S, NFD627940S, NFD627941S, NFD627942S, NFD627943S, NFD627944S, NFD627945S, NFD627946S, NFD627947S, NFD627948S, NFD627949S, NFD627950S, NFD627951S, NFD627952S, NFD627953S, NFD627954S, NFD627955S, NFD627956S, NFD627957S, NFD627958S, NFD627959S, NFD627960S, NFD627962S, NFD627965S, NFD627966S, NFD627968S, NFD627969S, NFD627970S, NFD627971S, NFD627973S, NFD627974S, NFD627975S, NFD627976S, NFD627977S, NFD627979S, NFD627981S, NFD627982S, NFD627983S, NFD627984S, NFD627985S, NFD627986S, NFD627987S, NFD627988S, NFD627989S, NFD627990S, NFD627993S, NFD627994S, NFD627996S, NFD627997S, NFD627998S, NFD628000S, NFD628001S, NFD628002S, NFD628003S, NFD628004S, NFD628005S, NFD628006S, NFD628007S, NFD628008S, NFD628009S, NFD628010S, NFD628011S, NFD628012S, NFD628014S, NFD628015S, NFD628016S, NFD628017S, NFD628019S, NFD628021S, NFD628022S, NFD628023S, NFD628024S, NFD628027S, NFD628028S, NFD628030S, NFD628031S, NFD628036S, NFD628039S, NFD628042S, NFD628043S, NFD628044S, NFD628046S, NFD628053S, NFD628055S, NFD628056S, NFD628057S, NFD628059S, NFD628061S, NFD628063S, NFD628074S, NFD628076S, NFD628079S, NFD628080S, NFD628082S, NFD628085S, NFD628086S, NFD628089S, NFD628092S, NFD628094S, NFD628102S, NFD628103S, NFD628109S, NFD628110S, NFD628114S, NFD628116S, NFD628120S, NFD628122S, NFD628125S, NFD628128S, NFD628129S, NFD628130S, NFD628131S, NFD628133S, NFD628134S, NFD628148S, NFD628153S, NFD628188S, NFD628191S, NFD628192S, NFD628195S, NFD628196S, NFD628197S, NFD628205S, NFD628207S, NFD628208S, NFD628210S, NFD628275S, NFD628283S, NFD628284S, NFD628286S, NFD628292S, NFD628293S, NFD628296S, NFD628298S, NFD628299S, NFD628300S, NFD628301S, NFD628304S, NFD628305S, NFD628306S, NFD628307S, NFD628308S, NFD628311S, NFD628312S, NFD628314S, NFD628315S, NFD628316S, NFD628320S, NFD628322S, NFD628323S, NFD628324S, NFD628325S, NFD628326S, NFD628327S, NFD628328S, NFD628329S, NFD628330S, NFD628331S, NFD628332S, NFD628333S, NFD628334S, NFD628335S, NFD628336S, NFD628337S, NFD628338S, NFD628339S, NFD628340S, NFD628342S, NFD628343S, NFD628344S, NFD628346S, NFD628347S, NFD628348S, NFD628349S, NFD628350S, NFD628351S, NFD628353S, NFD628354S, NFD628355S, NFD628357S, NFD628359S, NFD628362S, NFD628364S, NFD628365S, NFD628366S, NFD628367S, NFD628370S, NFD628371S, NFD628377S, NFD628378S, NFD628379S, NFD628383S, NFD628385S, and NFD628386S
• Recalling Firm/ Manufacturer: Medtronic Neuromodulation; 800 53rd Ave NE; PO Box 1250; Minneapolis MN 55440-1250
• For Additional Information Contact: 763-514-5174
• Manufacturer Reason for Recall: Cessation of Therapy: separation of internal connections (lifted wirebonds) between the electronic circuit and battery may lead to sudden cessation of therapy.
• FDA Determined Cause: Packaging change control
• Action: A letter "Medtronic Urgent: Device Recall" dated October 2007 was sent to Healthcare Professionals. The letter described the device defect, product involved, root cause, probability of occurrence, recommendations and also provided information for assistance. At the time of the recall all of the product remaining in date for use (not expired) had been implanted, therefore Medtronic provided Important Patient Management Information for the implanting physicians to use in patient care and decisions regarding patient explants.
• Quantity in Commerce: 1,427
• Distribution: Worldwide: USA including the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, ND, NE, NH, NJ, NM, NY, NV, OH, OK, OR, PA, RI, SC, SD, TN, TX, WA, WI, WY, UT, VA, VT, and WV and countries of Australia , Austria , Belgium , Canada , Cyprus , Czech Republic , Denmark , Finland , France , Germany , Greece , Hong Kong , Hungary , Iceland , India , Iran , Israel , Italy , Japan , Latin America, Lebanon , The Netherlands , Norway , Poland , Portugal , Russian Federation , Saudi Arabia , South Africa , Spain , Sweden , Switzerland , Turkey , and The United Kingdom
• 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.