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U.S. Department of Health and Human Services

Class 2 Device Recall Consulta CRTD

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  Class 2 Device Recall Consulta CRTD see related information
Date Initiated by Firm May 05, 2010
Date Posted October 21, 2010
Recall Status1 Terminated 3 on March 15, 2012
Recall Number Z-0111-2011
Recall Event ID 55922
PMA Number P010031S084 
Product Classification Defirbillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - Product Code NIK
Product Medtronic Consulta CRT-D, model D224TRK and Model D234TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA.
The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies.
Code Information Model D224TRK, serial numbers: PUD200144H, PUD200145H, PUD200147H thru PUD200166H, PUD200168H thru PUD200243H, PUD200245H thru PUD200272H, PUD200274H, PUD200275H, PUD200277H thru PUD200399H, PUD200401H thru PUD200409H, PUD200411H thru PUD200526H, PUD200528H thru PUD200651H, PUD200653H, PUD200655H thru PUD200755H, PUD200757H thru PUD201041H, PUD201043H thru PUD201150H, PUD201152H thru PUD201306H, PUD201308H thru PUD201311H, PUD201313H thru PUD201345H, PUD201347H thru PUD201374H, PUD201376H thru PUD201381H, PUD201383H thru PUD201387H, PUD201389H thru PUD201431H, PUD201433H thru PUD201435H, PUD201437H. PUD201439H, PUD201441H, PUD201444H thru PUD201513H, PUD201515H thru PUD201573H, PUD201575H thru PUD201596H, PUD201598H thru PUD201691H, PUD201694H thru PUD201734H, PUD201736H thru PUD201757H, PUD201759H thru PUD201764H, PUD201766H thru PUD201966H, PUD201968H thru PUD202049H, PUD202051H thru PUD202092H, PUD202094H thru PUD202120H, PUD202122H thru PUD202170H, PUD202172H thru PUD202192H, PUD202194H, PUD202195H, PUD202197H thru PUD202231H, PUD202233H thru PUD202252H, PUD202254H thru PUD202354H, PUD202356H thru PUD202366H, PUD202368H thru PUD202488H, PUD202490H thru PUD202505H, PUD202507H thru PUD202528H, PUD202530H thru PUD202579H, PUD202581H thru PUD202680H, PUD202682H thru PUD202698H, PUD202700H thru PUD202864H, PUD202866H thru PUD202926H, PUD202928H thru PUD203009H, PUD203011H thru PUD203086H, PUD203088H thru PUD203109H, PUD203111H thru PUD203145H, PUD203147H thru PUD203303H, PUD203305H thru PUD203320H, PUD203322H thru PUD203401H, PUD203403H thru PUD203660H, PUD203662H thru PUD203772H, PUD203774H thru PUD203814H, PUD203816H thru PUD203956H, PUD203958H thru PUD203976H, PUD203978H thru PUD204080H, PUD204082H thru PUD204158H, PUD204160H thru PUD204224H, PUD204226H thru PUD204282H, PUD204284H thru PUD204316H, PUD204318H thru PUD204322H, PUD204324H thru PUD204753H, PUD204755H thru PUD204769H, PUD204771H thru PUD204812H, PUD204814H, PUD204816H thru PUD204820H, PUD204822H thru PUD204979H, PUD204981H, PUD204982H, PUD204984H  thru PUD205156H, PUD205158H thru PUD205180H, PUD205182H thru PUD205213H, PUD205215H thru PUD205235H, PUD205237H thru PUD205241H, PUD205243H, PUD205251H, PUD205252H, PUD205254H thru PUD205457H, PUD205459H thru PUD205476H, PUD205478H thru PUD205537H, PUD205539H thru PUD205556H, PUD205558H thru PUD205561H, PUD205563H thru PUD205607H, PUD205609H thru PUD205736H, PUD205738H thru PUD206015H, PUD206017H thru PUD206105H, PUD206107H thru PUD206233H, PUD206235H thru PUD206242H, PUD206245H thru PUD206269H, PUD206271H thru PUD206313H, PUD206315H thru PUD206408H, PUD206410H thru PUD206436H, PUD206438H thru PUD206540H, PUD206542H thru PUD206649H, PUD206651H thru PUD206720H, PUD206722H thru PUD206903H, PUD206905H thru PUD206957H, PUD206959H thru PUD206985H, PUD206987H thru PUD207046H, PUD207048H thru PUD207076H, PUD207078H thru PUD207083H, PUD207085H thru PUD207096H, PUD207097H thru PUD207099H, PUD207101H thru PUD207175H, PUD207177H thru PUD207282H, PUD207285H thru PUD207366H, PUD207368H thru PUD207420H, PUD207422H thru PUD207562H, PUD207564H thru PUD207697H, PUD207699H thru PUD207731H, PUD207733H thru PUD207788H, PUD207790H thru PUD207934H, PUD207936H thru PUD207963H, PUD207965H thru PUD208121H, PUD208123H thru PUD208251H, PUD208253H thru PUD208306H, PUD208308H thru PUD208339H, PUD208341H thru PUD208475H, PUD208477H thru PUD208486H, PUD208488H thru PUD208530H, PUD208532H thru PUD208962H, PUD208964H thru PUD209021H, PUD209023H, PUD209031H, PUD209032H, PUD209034H thru PUD209080H, PUD209082H thru PUD209106H, PUD209108H thru PUD209113H, PUD209115H thru PUD209133H, PUD209135H thru PUD209205H, PUD209207H thru PUD209276H, PUD209278H thru PUD209328H, PUD209330H thru PUD209334H, PUD209336H thru PUD209399H, PUD209401H thru PUD209580H, PUD209582H thru PUD209613H, PUD209615H thru PUD209618H, PUD209620H thru PUD209720H, PUD209722H, PUD209724H thru PUD209747H, PUD209749H thru PUD210001H, PUD210003H thru PUD210010H, PUD210012H thru PUD210047H, PUD210049H thru PUD210111H, PUD210113H thru PUD210232H, PUD210234H thru PUD210346H, PUD210348H thru PUD210364H, PUD210366H thru PUD210551H, PUD210553H thru PUD210617H, PUD210619H thru PUD210770H, PUD210773H thru PUD210844H, PUD210846H thru PUD211033H, PUD211035H thru PUD211164H, PUD211166H thru PUD211190H, PUD211192H thru PUD211376H, PUD211378H thru PUD211396H, PUD211398H, PUD211399H, PUD211400H, PUD211401H, PUD211403H thru PUD211415H, PUD211417H thru PUD211453H, PUD211455H thru PUD211506H, PUD211508H thru PUD211591H, PUD211593H thru PUD211612H, PUD211614H, PUD211615H, PUD211617H thru PUD211685H, PUD211688H thru PUD211806H, PUD211808H thru PUD211840H, PUD211842H thru PUD211966H, PUD211968H thru PUD211978H, PUD211980H thru PUD212006H, PUD212008H thru PUD212014H, PUD212016H thru PUD212143H, PUD212145H thru PUD212739H, PUD212741H thru PUD212842H, PUD212844H thru PUD212966H, PUD212968H thru PUD213176H, PUD213178H thru PUD213415H, PUD213418H thru PUD213424H, PUD213426H thru PUD213444H, PUD213447H thru PUD213504H, PUD213506H thru PUD213635H, PUD213637H thru PUD213659H, PUD213661H thru PUD213682H, PUD213684H thru PUD213695H, PUD213698H thru PUD213743H, PUD213745H, PUD213747H thru PUD213816H, PUD213818H thru PUD213866H, PUD213871H thru PUD213949H, PUD213951H thru PUD214025H, PUD214027H thru PUD214051H, PUD214053H thru PUD214104H, PUD214106H thru PUD214163H, PUD214165H thru PUD214226H, PUD214229H PUD214230H, PUD214231H, PUD214232H, PUD214233H, PUD214235H, thru PUD214241H, PUD214243H thru PUD214344H, PUD214346H thru PUD214360H, PUD214362H thru PUD214437H, PUD214439H thru PUD214445H, PUD214447H thru PUD214477H, PUD214479H thru PUD214487H, PUD214489H thru PUD214649H, PUD214651H thru PUD214710H, PUD214712H thru PUD214741H, PUD214743H thru PUD215418H, PUD215420H thru PUD215719H, PUD215721H thru PUD215834H, PUD215836H thru PUD215885H, PUD215887H thru PUD215910H, PUD215912H thru PUD216001H, PUD216003H thru PUD216041H, PUD216043H thru PUD216086H, PUD216088H thru PUD216262H, PUD216264H thru PUD216294H, PUD216297H thru PUD216347H, PUD216353H thru PUD216372H, PUD216374H thru PUD216385H, PUD216387H thru PUD216400H, PUD216402H thru PUD216465H, PUD216467H thru PUD216968H, PUD216970H thru PUD217025H, PUD217027H thru PUD217049H, PUD217051H thru PUD217070H, PUD217072H thru PUD217138H, PUD217140H thru PUD217164H, PUD217166H thru PUD217254H, PUD217256H thru PUD217261H, PUD217263H thru PUD217317H, PUD217319H thru PUD217458H, PUD217460H thru PUD217464H, PUD217466H thru PUD217487H, PUD217489H thru PUD217494H, PUD217496H thru PUD217588H, PUD217590H thru PUD217638H, PUD217640H thru PUD217716H, PUD217718H thru PUD217962H, PUD217964H thru PUD218058H, PUD218060H thru PUD218108H, PUD218110H thru PUD218114H, PUD218116H thru PUD218165H, PUD218167H, PUD218169H thru PUD218221H, PUD218223H thru PUD218231H, PUD218233H thru PUD218256H, PUD218258H thru PUD218555H, PUD218557H thru PUD218615H, PUD218617H thru PUD218710H, PUD218712H thru PUD218825H, PUD218827H thru PUD218847H, PUD218849H thru PUD218899H, PUD218901H, PUD218902H, PUD218904H thru PUD219133H, PUD219135H thru PUD219145H, PUD219147H thru PUD219518H, PUD219520H thru PUD219627H, PUD219629H thru PUD219732H, PUD219734H, PUD219735H, PUD219736H, PUD219737H, PUD219738H, PUD219740H thru PUD219759H, PUD219761H thru PUD219856H, PUD219858H thru PUD220123H, PUD220125H thru PUD220150H, PUD220152H thru PUD220161H, PUD220163H thru PUD220263H, PUD220265H thru PUD220341H, PUD220343H thru PUD220484H, PUD220486H thru PUD220506H, PUD220508H thru PUD220635H, PUD220637H, PUD220638H thru PUD220727H, PUD220729H thru PUD220826H, PUD220828H thru PUD221320H, PUD221322H thru PUD221340H, PUD221343H PUD221344H, PUD221345H, PUD221346H, PUD221348H thru PUD221416H, PUD221418H thru PUD221570H, PUD221572H thru PUD221822H, PUD221824H thru PUD222146H, PUD222148H thru PUD222235H, PUD222237H thru PUD222322H, PUD222324H thru PUD222387H, PUD222389H thru PUD222453H, PUD222455H thru PUD222578H, PUD222580H thru PUD222631H, PUD222633H thru PUD222779H, PUD222781H thru PUD222795H, PUD222796H thru PUD222813H, PUD222815H thru PUD222886H, PUD222888H thru PUD223026H, PUD223028H thru PUD223106H, PUD223108H thru PUD223191H, PUD223193H thru PUD223212H, PUD223215H, PUD223217H thru PUD223578H, PUD223580H thru PUD223599H, PUD223601H, PUD223602H, PUD223604H, PUD223605H, PUD223607H thru PUD223631H, PUD223633H thru PUD223704H, PUD223706H thru PUD223877H, PUD223879H thru PUD223909H, PUD223911H thru PUD223917H, PUD223919H thru PUD223928H, PUD223930H thru PUD223959H, PUD223961H, PUD223962H, PUD223964H thru PUD223990H, PUD223992H thru PUD224000H, PUD224002H thru PUD224019H, PUD224023H PUD224029H, PUD224031H, PUD224036H, PUD224038H, PUD224040H, PUD224041H, PUD224046H thru PUD224053H, PUD224055H thru PUD224123H, PUD224125H thru PUD224210H, PUD224213H thru PUD224223H, PUD224225H thru PUD224241H, PUD224243H thru PUD224251H, PUD224253H thru PUD224283H, PUD224285H thru PUD224407H, PUD224409H thru PUD224498H, PUD224500H thru PUD224520H, PUD224522H thru PUD224841H, PUD224843H thru PUD224864H, PUD224866H thru PUD225057H, PUD225059H thru PUD225084H, PUD225086H, PUD225088H thru PUD225101H, PUD225103H thru PUD225107H, PUD225109H, PUD225111H thru PUD225263H, PUD225265H thru PUD225352H, PUD225354H thru PUD225417H, PUD225419H thru PUD225520H, PUD225522H thru PUD225542H, PUD225544H thru PUD225785H, PUD225787H thru PUD226007H, PUD226009H thru PUD226041H, PUD226043H thru PUD226121H, PUD226123H thru PUD226148H, PUD226150H thru PUD226218H, PUD226220H thru PUD226331H, PUD226333H thru PUD226425H, PUD226427H thru PUD226471H, PUD226473H thru PUD226607H, PUD226609H, PUD226610H, PUD226611H, PUD226613H thru PUD226626H, PUD226628H, PUD226629H, PUD226630H, PUD226631H, PUD226633H thru PUD226656H, PUD226658H thru PUD226731H, PUD226733H thru PUD226738H, PUD226740H thru PUD226778H, PUD226780H thru PUD226884H, PUD226886H thru PUD227063H, PUD227065H thru PUD227097H, PUD227099H thru PUD227104H, PUD227106H thru PUD227143H, PUD227145H thru PUD227220H, PUD227222H thru PUD227299H, PUD227301H thru PUD227387H, PUD227389H, PUD227391H thru PUD227549H, PUD227551H thru PUD227604H, PUD227606H thru PUD227655H, PUD227657H thru PUD227913H, PUD227915H thru PUD228276H, PUD228278H thru PUD228343H, PUD228345H thru PUD228402H, PUD228404H thru PUD228419H, PUD228421H thru PUD228515H, PUD228517H thru PUD228602H, PUD228604H thru PUD228631H, PUD228637H thru PUD228909H, PUD228911H thru PUD228936H, PUD228938H thru PUD228967H, PUD228969H thru PUD229156H, PUD229158H thru PUD229245H, PUD229247H thru PUD229363H, PUD229365H thru PUD229532H, PUD229534H thru PUD229541H, PUD229543H thru PUD229641H, PUD229643H thru PUD229669H, PUD229671H thru PUD229677H, PUD229679H thru PUD229698H, PUD229700H thru PUD229716H, PUD229718H thru PUD229861H, PUD229863H thru PUD229874H, PUD229876H thru PUD230053H, PUD230055H thru PUD230073H, PUD230075H, PUD230076H, PUD230077H, PUD230079H thru PUD230170H, PUD230172H thru PUD230201H, PUD230203H thru PUD230309H, PUD230311H thru PUD230578H, PUD230580H thru PUD230651H, PUD230653H thru PUD230704H, PUD230706H thru PUD230951H, PUD230953H thru PUD230959H, PUD230961H thru PUD231036H, PUD231038H thru PUD231227H, PUD231229H, PUD231230H, PUD231231H, PUD231233H thru PUD231339H, PUD231341H thru PUD231505H, PUD231507H thru PUD231853H, PUD231855H thru PUD232009H, PUD232011H thru PUD232020H, PUD232022H thru PUD232073H, PUD232075H thru PUD232113H, PUD232115H thru PUD232176H, PUD232178H, PUD232179H, PUD232180H, PUD232182H thru PUD232199H, PUD232201H thru PUD232319H, PUD232321H thru PUD232433H, PUD232435H thru PUD232442H, PUD232444H, PUD232445H, PUD232447H thru PUD232483H, PUD232485H thru PUD232593H, PUD232595H thru PUD233441H, PUD233443H thru PUD233614H, PUD233616 thru PUD233640H, PUD233642H thru PUD233864H, PUD233866H thru PUD233880H, PUD233882H, PUD233883H, PUD233884H, PUD233885H, PUD233886H, PUD233887H, PUD233889H thru PUD233912H, PUD233914H thru PUD234085H, PUD234087H thru PUD234390H, PUD234392H thru PUD234473H. PUD234476H thru PUD234495H, PUD234497H thru PUD234647H, PUD234649H thru PUD234664H. PUD234666H thru PUD234724H, PUD234726H thru PUD234862H, PUD234864H thru PUD235017H, PUD235019H thru PUD235224H, PUD235226H thru PUD235253H, PUD235255H thru PUD235277H, PUD235279H thru PUD235353H, PUD235355H thru PUD235397H, PUD235399H thru PUD235448H, PUD235450H thru PUD235644H, PUD235646H, PUD235647H, PUD235648H, PUD235649H, PUD235651H thru PUD235743H, PUD235745H thru PUD235775H, PUD235777H thru PUD235795H, PUD235797H, PUD235798H, PUD235799H, PUD235800H, PUD235801H, PUD235805H thru PUD235871H, PUD235877H,, PUD235882H thru PUD235930H, PUD235933H thru PUD235984H, PUD236092H, PUD236094H thru PUD236119H, PUD236121H thru PUD236152H, PUD236154H thru PUD236283H, PUD236285H thru PUD236508H, PUD236510H, PUD236511H, PUD236512H, PUD236518H thru PUD236556H, PUD236558H thru PUD236563H, PUD236565H thru PUD236584H, PUD236794H, PUD236797H, PUD236800H, PUD236802H, PUD236805H, PUD600062S, PUD600063S, PUD600081S, PUD600082S, PUD600083S, PUD600084S, PUD600086S, PUD600087S, PUD600089S, PUD600090S, PUD600091S, PUD600094S thru PUD600152S, PUD600154S thru PUD600185S, PUD600187S thru PUD600193S, PUD600195S thru PUD600268S, PUD600270S thru PUD600658S, PUD600660S thru PUD600793S, PUD600794S.   
Recalling Firm/
Manufacturer		 Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact
763-514-4000
Manufacturer Reason
for Recall		 Medtronic is informing you of a rare device software issue in certain ICD and CRT-D devices. A software update will be available to correct his issue. There have been 5 reports of this issue occurring with no reported patient injuries or deaths. Medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. In the u
FDA Determined
Cause 2		 Software design
Action Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected. For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.
Quantity in Commerce 53,178
Distribution Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.
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 = NIK and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = NIK and Original Applicant = Medtronic, Inc.
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