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U.S. Department of Health and Human Services

Class 2 Device Recall Concerto II CRTD

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 Class 2 Device Recall Concerto II CRTD see related information
Date Posted October 21, 2010
Recall Status1 Terminated on March 15, 2012
Recall Number Z-0110-2011
Recall Event ID 55922
PMA Number P010031S125 
Product Classification Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - Product Code NIK
Product Medtronic Concerto II CRT-D, model D274TRK and Model D294TRK not available in the US. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (DDE-DDR). 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 213936H thru PZV214168H, PZV214171H thru PZV214191H, PZV214193H thru PZV214276H, PZV214278H thru PZV214390H, PZV214392H thru PZV214400H, PZV214402H thru PZV214419H, PZV214421H thru PZV214660H, PZV214662H thru PZV214691H, PZV214693H thru PZV214754H, PZV214756H thru PZV214781H, PZV214783H thru PZV214862H, PZV214865H thru PZV214893H, PZV214895H thru PZV214918H, PZV214921H, PZV214923H thru PZV214966H, PZV214968H thru PZV214981H, PZV214983H, PZV214984H, PZV214986H thru PZV214994H, PZV214996H thru PZV215033H, PZV215035H thru PZV215235H, PZV215237H thru PZV215253H, PZV215255H thru PZV215262H, PZV215264H thru PZV215353H, PZV215355H thru PZV215381H, PZV215383H thru PZV215492H, PZV215494H thru PZV215663H, PZV215665H thru PZV215696H, PZV215698H, PZV215702H, PZV215704H, PZV215705H, PZV215707H, PZV215711H thru PZV215714H, PZV215716H, PZV215719H thru PZV215725H, PZV215754H, PZV215755H, PZV215757H, PZV215759H, PZV215760H, PZV215761H, PZV215763H, PZV215765H, PZV215782H, PZV215784H, PZV215787H, PZV215789H, PZV215790H, PZV215791H, PZV215792H, PZV215793H, PZV215813H, PZV215816H, PZV215818H, PZV215820H, PZV215823H, PZV215845H, PZV215864H, PZV215929H, PZV215930H, PZV215932H, PZV215934H, PZV215936H, PZV215957H, PZV215958H, PZV216041H.



Model D294TRK, serial numbers: PZU600001S thru PZU600035S, PZU600037S thru PZU600110S , PZU600112S thru PZU600213S , PZU600215S thru PZU600234S, PZU600236S thru PZU600417S, PZU600419S thru PZU600549S, PZU600551S thru PZU600692S, PZU600694S, PZU600695S, PZU600697S thru PZU600739S, PZU600741S thru PZU600805S, PZU600807S thru PZU600827S, PZU600829S thru PZU600840S, PZU600842S thru PZU601052S, PZU601054S thru PZU601289S, PZU601291S thru PZU601507S, PZU601509S thru PZU601720S, PZU601722S thru PZU601786S, PZU601788S thru PZU602260S, PZU602262S thru PZU602512S, PZU602514S thru PZU602527S, PZU602529S thru PZU602579S, PZU602581S thru PZU602799S, PZU602801S thru PZU602926S, PZU602928S thru PZU603200S, PZU603202S thru PZU603212S, PZU603215S thru PZU603264S.
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 18,778
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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