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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 Posted October 21, 2010
Recall Status1 Terminated 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 D210049H 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, PUD222
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
763-514-4000
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
PMA Database PMAs with Product Code = NIK and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
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