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U.S. Department of Health and Human Services

Class 2 Device Recall Virtuoso II VR

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  Class 2 Device Recall Virtuoso II VR 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-0118-2011
Recall Event ID 55922
PMA Number P010031S125 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code NIK
Product Medtronic Virtuoso II VR, model D274VRC, and model D294VRC not available in the U.S.. Digital Single chamber implantable cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA.
The Single chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single chamber rate-responsive bradycardia pacing, and ventricular tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
Code Information Model D274VRC, serial numbers: PZR200006H thru PZR200042H, PZR200044H thru PZR200082H, PZR200084H thru PZR200384H, PZR200386H thru PZR200423H, PZR200425H thru PZR200507H, PZR200509H thru PZR200890H, PZR200892H thru PZR200981H, PZR200983H thru PZR201096H, PZR201098H thru PZR201257H, PZR201259H thru PZR201327H, PZR201329H thru PZR201351H, PZR201353H, PZR201354H, PZR201355H, PZR201356H, PZR201357H, PZR201358H, PZR201359H, PZR201360H, PZR201361H, PZR201362H, PZR201363H, PZR201364H, PZR201365H, PZR201367H thru PZR201490H, PZR201492H, PZR201493H, PZR201494H, PZR201495H, PZR201496H, PZR201497H, PZR201498H, PZR201499H, PZR201500H, PZR201501H, PZR201502H, PZR201503H, PZR201505H thru PZR201553H, PZR201555H thru PZR201696H, PZR201698H thru PZR201754H, PZR201756H, PZR201757H, PZR201758H, PZR201759H, PZR201760H, PZR201761H, PZR201762H, PZR201763H, PZR201765H thru PZR201827H, PZR201829H thru PZR201878H, PZR201879H, PZR201880H, PZR201881H, PZR201882H, PZR201883H, PZR201885H, PZR201886H, PZR201887H, PZR201888H, PZR201889H, PZR201890H, PZR201891H, PZR201893H, PZR201894H, PZR201895H, PZR201896H, PZR201897H, PZR201898H, PZR201899H, PZR201900H, PZR201901H, PZR201902H, PZR201903H, PZR201904H, PZR201905H, PZR201907H thru PZR201940H, PZR201942H thru PZR202011H, PZR202013H thru PZR202042H, PZR202044H thru PZR202101H, PZR202103H, PZR202104H, PZR202105H, PZR202106H, PZR202107H, PZR202108H, PZR202109H, PZR202110H, PZR202111H, PZR202112H, PZR202113H, PZR202114H, PZR202115H, PZR202116H, PZR202117H, PZR202118H, PZR202119H, PZR202121H thru PZR202212H, PZR202214H thru PZR202339H, PZR202341H, PZR202342H, PZR202343H, PZR202344H, PZR202345H, PZR202346H, PZR202347H, PZR202348H, PZR202349H, PZR202351H thru PZR202396H, PZR202398H thru PZR202471H, PZR202473H thru PZR202511H, PZR202514H thru PZR202539H, PZR202541H, PZR202542H, PZR202544H, PZR202545H, PZR202546H, PZR202548H thru PZR202647H, PZR202649H thru PZR202664H, PZR202666H thru PZR202686H, PZR202688H thru PZR202777H, PZR202779H thru PZR202798H, PZR202800H thru PZR202822H, PZR202824H thru PZR203026H, PZR203028H thru PZR203093H, PZR203095H, PZR203096H, PZR203098H thru PZR203247H, PZR203249H thru PZR203392H, PZR203394H thru PZR203419H, PZR203421H thru PZR203448H, PZR203450H thru PZR203661H, PZR203663H thru PZR203693H, PZR203695H, PZR203696H, PZR203697H, PZR203698H, PZR203699H, PZR203700H, PZR203701H, PZR203702H, PZR203703H, PZR203704H, PZR203705H, PZR203706H, PZR203707H, PZR203708H, PZR203709H, PZR203710H, PZR203711H, PZR203713H thru PZR203767H, PZR203769H thru PZR203823H, PZR203825H, PZR203826H, PZR203828H thru PZR204001H, PZR204003H thru PZR204120H, PZR204122H, PZR204123H, PZR204125H, PZR204126H, PZR204127H, PZR204128H, PZR204130H thru PZR204151H, PZR204153H, PZR204154H, PZR204156H thru PZR204209H, PZR204211H thru PZR204272H, PZR204274H, PZR204276H, PZR204277H, PZR204278H, PZR204279H, PZR204280H, PZR204281H, PZR204282H, PZR204283H, PZR204284H, PZR204285H, PZR204286H, PZR204288H thru PZR204500H, PZR204502H, PZR204503H, PZR204504H, PZR204505H, PZR204506H, PZR204507H, PZR204508H, PZR204509H, PZR204510H, PZR204511H, PZR204512H, PZR204513H, PZR204514H, PZR204515H, PZR204516H, PZR204518H, PZR204519H, PZR204520H, PZR204521H, PZR204522H, PZR204523H, PZR204524H, PZR204525H, PZR204526H, PZR204527H, PZR204528H, PZR204529H, PZR204530H, PZR204531H, PZR204532H, PZR204533H, PZR204534H, PZR204535H, PZR204536H, PZR204537H, PZR204538H, PZR204539H, PZR204540H, PZR204541H, PZR204543H thru PZR204579H, PZR204581H thru PZR204654H, PZR204656H thru PZR204709H, PZR204711H thru PZR204828H, PZR204836H, PZR204838H thru PZR204869H, PZR204871H thru PZR204965H, PZR204967H thru PZR204987H, PZR204989H thru PZR205022H, PZR205024H thru PZR205055H, PZR205057H thru PZR205100H, PZR205102H thru PZR205121H, PZR205123H thru PZR205160H, PZR205162H thru PZR205188H.   Model D294VRC, serial numbers: PZQ600001S thru PZQ600167S, PZQ600169S thru PZQ600481S, PZQ600483S, PZQ600484S, PZQ600486S thru PZQ600550S, PZQ600552S, PZQ600553S, PZQ600554S, PZQ600555S, PZQ600556S, PZQ600557S, PZQ600559S thru PZQ600735S, PZQ600737S thru PZQ600822S, PZQ600825S thru PZQ600872S, PZQ600874S thru PZQ600911S, PZQ600913S thru PZQ600994S, PZQ600996S, PZQ600997S, PZQ600998S, PZQ600999S, PZQ601000S, PZQ601001S, PZQ601002S, PZQ601004S, PZQ601005S, PZQ601006S, PZQ601007S, PZQ601008S, PZQ601009S, PZQ601010S, PZQ601012S thru PZQ601170S, PZQ601172S thru PZQ601188S, PZQ601190S, PZQ601191S, PZQ601192S, PZQ601193S, PZQ601194S, PZQ601195S, PZQ601196S, PZQ601197S, PZQ601198S, PZQ601200S thru PZQ601251S, PZQ601253S, PZQ601254S, PZQ601255S, PZQ601256S, PZQ601258S thru PZQ601502S, PZQ601504S thru PZQ601594S, PZQ601596S, PZQ601597S, PZQ601598S, PZQ601599S, PZQ601600S. 
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 6674
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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