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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 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
Premarket Approval
PMA Number
P010031/S125
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 Model D274TRK, serial numbers: PZV200009H thru PZV200026H, PZV200028H thru PZV200043H, PZV200045H thru PZV200077H, PZV200079H thru PZV200113H, PZV200115H thru PZV200281H, PZV200283H, PZV200285H thru PZV200318H, PZV200320H thru PZV200332H. PZV200334H thru PZV200354H, PZV200356H thru PZV200414H, PZV200416H thru PZV200548H, PZV200550H thru PZV200555H, PZV200557H thru PZV200645H, PZV200647H, PZV200648H thru PZV200783H, PZV200785H thru PZV200950H, PZV200952H thru PZV201125H, PZV201128H thru PZV201184H, PZV201186H thru PZV201232H, PZV201234H thru PZV201423H, PZV201425H thru PZV201501H, PZV201503H thru PZV201622H, PZV201624H thru PZV201834H, PZV201836H thru PZV201960H, PZV201963H thru PZV202137H, PZV202139H thru PZV202368H, PZV202370H thru PZV202458H, PZV202460H thru PZV202629H, PZV202631H thru PZV202692H, PZV202694H thru PZV202885H, PZV202887H thru PZV203066H, PZV203068H thru PZV203152H, PZV203154H thru PZV203196H, PZV203198H thru PZV203293H, PZV203296H thru PZV203300H, PZV203302H thru PZV203372H, PZV203374H thru PZV203527H, PZV203529H thru PZV203637H, PZV203639H thru PZV203654H, PZV203656H thru PZV203723H, PZV203725H thru PZV203748H, PZV203750H thru PZV203911H, PZV203913H, PZV203914H, PZV203915H, PZV203917H thru PZV204157H, PZV204159H thru PZV204194H, PZV204196H thru PZV204408H, PZV204410H thru PZV204763H, PZV204765H thru PZV204869H, PZV204872H thru PZV205216H, PZV205218H thru PZV205229H, PZV205231H thru PZV205332H. PZV205335H thru PZV205368H, PZV205370H thru PZV205420H, PZV205422H thru PZV205444H, PZV205446H thru PZV205490H, PZV205492H thru PZV205542H, PZV205544H thru PZV205604H, PZV205606H thru PZV205691H, PZV205693H thru PZV205696H, PZV205698H thru PZV205784H, PZV205786H thru PZV205795H, PZV205797H thru PZV205848H, PZV205850H thru PZV205953H, PZV205955H thru PZV205966H, PZV205968H thru PZV206175H, PZV206177H thru PZV206276H, PZV206279H, PZV206280H, PZV206282H thru PZV206458H, PZV206460H thru PZV206541H, PZV206544H thru PZV206575H, PZV206578H, PZV206580H thru PZV206627H, PZV206629H thru PZV206636H, PZV206638H thru PZV206689H, PZV206692H thru PZV206727H, PZV206729H thru PZV206759H, PZV206761H thru PZV206827H, PZV206829H thru PZV206946H, PZV206948H thru PZV207176H, PZV207178H thru PZV207271H, PZV207273H, PZV207274H, PZV207276H thru PZV207278H, PZV207280H thru PZV207292H, PZV207294H thru PZV207598H, PZV207600H thru PZV207625H, PZV207627H thru PZV207885H, PZV207887H thru PZV207934H, PZV207936H thru PZV208044H, PZV208046H thru PZV208091H, PZV208093H thru PZV208101H, PZV208103H thru PZV208109H, PZV208111H thru PZV208184H, PZV208186H thru PZV208278H, PZV208280H thru PZV208309H, PZV208311H thru PZV208334H, PZV208336H thru PZV208487H, PZV208489H thru PZV208591H, PZV208593H thru PZV208669H, PZV208671H thru PZV208725H, PZV208727H thru PZV208740H, PZV208742H thru PZV208871H, PZV208873H thru PZV208934H, PZV208936H thru PZV209034H, PZV209036H thru PZV209072H, PZV209074H thru PZV209113H, PZV209115H thru PZV209248H, PZV209250H thru PZV209337H, PZV209339H thru PZV209650H, PZV209652H thru PZV209682H, PZV209684H thru PZV209818H, PZV209820H, PZV209821H, PZV209823H thru PZV209940H, PZV209942H thru PZV209967H, PZV209969H thru PZV210050H, PZV210052H thru PZV210334H, PZV210337H thru PZV210614H, PZV210616H thru PZV210814H, PZV210816H thru PZV210998H, PZV211000H thru PZV211045H, PZV211047H thru PZV211252H, PZV211254H thru PZV211358H, PZV211360H thru PZV211390H, PZV211392H thru PZV211467H, PZV211469H thru PZV211635H, PZV211637H thru PZV211834H, PZV211836H thru PZV211886H, PZV211888H thru PZV212032H, PZV212034H thru PZV212071H, PZV212073H thru PZV212267H, PZV212269H thru PZV212343H, PZV212344H thru PZV212411H, PZV212413H thru PZV212626H, PZV212628H thru PZV212817H, PZV212819H thru PZV212939H, PZV212941H thru PZV213225H, PZV213227H thru PZV213322H, PZV213324H thru PZV213356H, PZV213358H thru PZV213464H, PZV213466H thru PZV213485H, PZV213487H, PZV213493H thru PZV213544H, PZV213546H thru PZV213734H, PZV213736H thru PZV213779H, PZV213781H thru PZV213934H, PZV213936H 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, Minnesota 55112
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 Applicant = MEDTRONIC INC.
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