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U.S. Department of Health and Human Services

Class 2 Device Recall Virtuoso II DR

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 Class 2 Device Recall Virtuoso II DR see related information
Date Posted October 21, 2010
Recall Status1 Terminated on March 15, 2012
Recall Number Z-0117-2011
Recall Event ID 55922
PMA Number P010031S125 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code NIK
Product Medtronic Virtuoso II DR, model D274DRG, and model D294DRG not available in the U.S.. Digital Dual chamber implantable cardioverter defibrillator (DDE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA.
The Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia 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. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
Code Information Model D274DRG, serial numbers: PZT200009H thru PZT200032H, PZT200034H thru PZT200115H, PZT200117H thru PZT200313H, PZT200315H thru PZT200384H, PZT200386H thru PZT200408H, PZT200410H thru PZT200544H, PZT200546H thru PZT200596H, PZT200598H thru PZT200618H, PZT200620H thru PZT200762H, PZT200764H thru PZT200805H, PZT200807H thru PZT200866H, PZT200868H thru PZT200997H, PZT200999H, PZT201000H, PZT201001H, PZT201002H, PZT201003H, PZT201004H, PZT201005H, PZT201006H, PZT201007H, PZT201008H, PZT201009H, PZT201010H, PZT201012H, PZT201013H, PZT201014H, PZT201015H, PZT201016H, PZT201017H, PZT201018H, PZT201019H, PZT201020H, PZT201021H, PZT201022H, PZT201023H, PZT201024H, PZT201025H, PZT201026H, PZT201027H, PZT201028H, PZT201029H, PZT201030H, PZT201031H, PZT201032H, PZT201033H, PZT201034H, PZT201035H, PZT201036H, PZT201037H, PZT201039H thru PZT201069H, PZT201071H, PZT201072H, PZT201076H thru PZT201116H, PZT201118H thru PZT201287H, PZT201289H thru PZT201408H, PZT201410H, PZT201411H, PZT201413H thru PZT201556H, PZT201558H thru PZT201622H, PZT201624H thru PZT201763H, PZT201765H thru PZT201818H, PZT201820H thru PZT201920H, PZT201922H thru PZT201943H, PZT201945H thru PZT202123H, PZT202125H thru PZT202316H, PZT202318H thru PZT202350H, PZT202352H thru PZT202420H, PZT202422H, thru PZT202485H, PZT202486H, PZT202487H, PZT202488H, PZT202490H thru PZT202991H, PZT202993H thru PZT203234H, PZT203236H thru PZT203450H, PZT203452H thru PZT203539H, PZT203542H thru PZT203596H, PZT203598H thru PZT203634H, PZT203636H thru PZT203694H, PZT203696H thru PZT203784H, PZT203786H, PZT203789H thru PZT203839H, PZT203841H, PZT203842H, PZT203843H, PZT203844H, PZT203845H, PZT203846H, PZT203848H, PZT203849H thru PZT203886H, PZT203888H thru PZT203961H, PZT203963H thru PZT204021H, PZT204024H thru PZT204071H, PZT204074H, PZT204075H, PZT204076H, PZT204077H, PZT204078H, PZT204079H, PZT204080H, PZT204081H, PZT204082H, PZT204084H thru PZT204174H, PZT204176H, PZT204177H, PZT204178H, PZT204179H, PZT204180H, PZT204181H, PZT204182H, PZT204183H, PZT204185H thru PZT204324H, PZT204326H, PZT204327H, PZT204328H, PZT204329H, PZT204330H, PZT204331H, PZT204332H, PZT204333H, PZT204334H, PZT204335H, PZT204336H, PZT204337H, PZT204339H, PZT204340H, PZT204341H, PZT204342H, PZT204343H, PZT204344H, PZT204345H, PZT204346H, PZT204347H, PZT204348H, PZT204349H, PZT204350H, PZT204351H, PZT204352H, PZT204353H, PZT204355H, PZT204356H, PZT204357H, PZT204358H, PZT204359H, PZT204360H, PZT204361H, PZT204362H, PZT204363H, PZT204364H, PZT204365H, PZT204366H, PZT204367H, PZT204368H, PZT204369H, PZT204370H, PZT204372H thru PZT204400H, PZT204402H thru PZT204419H, PZT204421H thru PZT204581H, PZT204583H thru PZT204693H, PZT204695H thru PZT204748H, PZT204750H, PZT204751H, PZT204752H, PZT204753H, PZT204754H, PZT204755H, PZT204758H thru PZT204781H, PZT204783H thru PZT204916H, PZT204918H, PZT204919H, PZT204920H, PZT204921H, PZT204922H, PZT204923H, PZT204924H, PZT204925H, PZT204927H thru PZT204962H, PZT204964H, PZT204965H, PZT204966H, PZT204967H, PZT204968H, PZT204969H, PZT204970H, PZT204971H, PZT204972H, PZT204973H, PZT204974H, PZT204975H, PZT204976H, PZT204977H, PZT204978H, PZT204979H, PZT204980H, PZT204981H, PZT204982H, PZT204983H, PZT204984H, PZT204985H, PZT204986H thru PZT204987H, PZT204989H thru PZT205039H, PZT205041H thru PZT205208H, PZT205210H, PZT205211H, PZT205213H, PZT205214H, PZT205215H, PZT205216H, PZT205217H, PZT205218H, PZT205219H, PZT205220H, PZT205221H, PZT205222H, PZT205223H, PZT205224H, PZT205225H, PZT205226H, PZT205227H, PZT205228H, PZT205229H, PZT205230H, PZT205232H, PZT205233H, PZT205234H, PZT205235H, PZT205236H, PZT205237H, PZT205238H, PZT205239H, PZT205240H, PZT205241H, PZT205242H, PZT205243H, PZT205244H, PZT205245H, PZT205246H, PZT205247H, PZT205249H thru PZT205271H, PZT205273H thru PZT205302H, PZT205304H, PZT205305H, PZT205306H, PZT205308H thru PZT205449H, PZT205451H, PZT205454H, PZT205455H, PZT205456H, PZT205457H, PZT205458H, PZT205459H, PZT205460H, PZT205461H, PZT205462H, PZT205463H, PZT205464H,
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 13620
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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