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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 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
Premarket Approval
PMA Number
P980016/S114
Product Classification Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) - 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, PZT205466H thru PZT205573H, PZT205575H, PZT205576H, PZT205577H, PZT205578H, PZT205579H, PZT205580H, PZT205581H, PZT205583H thru PZT205660H, PZT205662H, PZT205663H, PZT205664H, PZT205665H, PZT205667H thru PZT205755H, PZT205758H thru PZT206498H, PZT206500H thru PZT206584H, PZT206586H thru PZT206647H, PZT206649H thru PZT206736H, PZT206738H thru PZT206859H, PZT206861H thru PZT206942H, PZT206944H thru PZT207002H, PZT207004H thru PZT207015H, PZT207017H thru PZT207076H, PZT207078H thru PZT207214H, PZT207216H thru PZT207234H, PZT207236H thru PZT207320H, PZT207322H thru PZT207491H, PZT207493H thru PZT207611H, PZT207613H thru PZT207655H, PZT207657H thru PZT207688H, PZT207690H, PZT207692H thru PZT207790H, PZT207792H thru PZT207888H, PZT207890H thru PZT207930H, PZT207932H thru PZT207957H, PZT207959H thru PZT208008H, PZT208010H thru PZT208103H, PZT208105H, PZT208107H thru PZT208180H, PZT208182H thru PZT208218H, PZT208220H thru PZT208399H, PZT208401H thru PZT208418H, PZT208420H, PZT208421H, PZT208422H, PZT208423H, PZT208424H, PZT208425H, PZT208426H, PZT208427H, PZT208428H, PZT208429H, PZT208430H, PZT208431H, PZT208432H, PZT208434H thru PZT208541H thru PZT208613H, PZT208615H thru PZT208759H, PZT208762H thru PZT208824H, PZT208826H thru PZT208904H, PZT208906H thru PZT208953H, PZT208955H thru PZT209095H, PZT209097H, PZT209098H, PZT209099H, PZT209101H, PZT209102H, PZT209103H, PZT209104H, PZT209105H, PZT209106H, PZT209107H, PZT209111H, PZT209112H, PZT209113H, PZT209115H thru PZT209177H, PZT209179H, PZT209180H, PZT209181H, PZT209182H, PZT209183H, PZT209184H, PZT209185H, PZT209187H thru PZT209218H, PZT209220H thru PZT209454H, PZT209456H, PZT209457H, PZT209458H, PZT209459H, PZT209460H, PZT209461H, PZT209462H, PZT209464H thru PZT209483H, PZT209485H thru PZT209532H, PZT209534H thru PZT209567H, PZT209569H, PZT209571H, PZT209572H, PZT209573H, PZT209575H thru PZT209613H, PZT209615H thru PZT209682H, PZT209684H thru PZT209898H, PZT209900H thru PZT210047H, PZT210049H thru PZT210105H, PZT210107H, PZT210108H, PZT210109H, PZT210110H, PZT210112H thru PZT210147H, PZT210149H thru PZT210201H, PZT210203H thru PZT210248H, PZT210250H thru PZT210353H, PZT210355H thru PZT210456H, PZT210460H thru PZT210479H, PZT210481H, PZT210483H, PZT210485H thru PZT210562H, PZT210564H thru PZT210579H, PZT210581H thru PZT210779H, PZT210781H thru PZT210874H, PZT210876H, PZT210878H thru PZT211040H, PZT211042H, PZT211044H thru PZT211117H, PZT211119H, PZT211120H, PZT211121H, PZT211122H, PZT211124H, PZT211125H thru PZT211232H, PZT211234H, PZT211235H, PZT211236H, PZT211238H thru PZT211297H, PZT211299H, PZT211300H, PZT211301H, PZT211302H, PZT211303H, PZT211304H, PZT211305H, PZT211306H, PZT211307H, PZT211308H, PZT211310H thru PZT211489H, PZT211491H thru PZT211527H, PZT211529H thru PZT211554H, PZT211556H thru PZT211672H, PZT211674H thru PZT211690H, PZT211692H, PZT211694H thru PZT211708H, PZT211710H thru PZT211794H, PZT211797H thru PZT211830H, PZT211832H, PZT211833H, PZT211834H, PZT211835H, PZT211836H, PZT211837H, PZT211838H thru PZT211887H, PZT211889H thru PZT211915H. Model D294DRG, serial numbers: PZS600001S thru PZS600076S, PZS600078S thru PZS600229S, PZS600231S thru PZS600425S, PZS600427S, PZS600428S, PZS600429S, PZS600430S, PZS600431S, PZS600432S, PZS600433S, PZS600434S, PZS600435S, PZS600436S, PZS600438S thru PZS600660S, PZS600662S thru PZS600742S, PZS600744S, PZS600745S, PZS600746S, PZS600747S, PZS600749S, PZS600750S, PZS600751S, PZS600752S, PZS600753S, PZS600754S, PZS600755S, PZS600756S, PZS600757S, PZS600758S, PZS600759S, PZS600760S, PZS600762S, PZS600763S, PZS600764S, PZS600765S, PZS600767S, PZS600768S, PZS600769S, PZS600770S, PZS600771S, PZS600772S, PZS600773S, PZS600775S, PZS600778S, PZS600779S, PZS600781S, PZS600783S, PZS600785S, PZS600786S, PZS600788S thru PZS600823S, PZS600825S thru PZS601174S, PZS601176S thru PZS601413S, PZS601415S thru PZS601804S, PZS601806S thru PZS601836S, PZS601838S thru PZS601883S, PZS601885S, PZS601887S thru PZS601917S.
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 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 Applicant = MEDTRONIC INC.
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