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U.S. Department of Health and Human Services

Class 2 Device Recall Maximo II VR

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  Class 2 Device Recall Maximo II VR see related information
Date Initiated by Firm May 05, 2010
Date Posting Updated October 21, 2010
Recall Status1 Terminated 3 on March 15, 2012
Recall Number Z-0114-2011
Recall Event ID 55922
PMA Number P980016S114 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code LWS
Product Medtronic Maximo II VR, model D284VRC. 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 D284VRC, serial numbers: PZN200002H thru PZN200019H, PZN200021H, PZN200022H, PZN200023H, PZN200024H, PZN200025H, PZN200026H, PZN200027H, PZN200029H thru PZN200044H, PZN200046H thru PZN200067H, PZN200069H thru PZN200108H, PZN200110H thru PZN200118H, PZN200120H, PZN200121H, PZN200123H thru PZN200139H, PZN200143H, PZN200144H, PZN200145H, PZN200146H, PZN200147H, PZN200148H, PZN200149H, PZN200150H, PZN200151H, PZN200152H, PZN200153H, PZN200154H, PZN200155H, PZN200156H, PZN200157H, PZN200158H, PZN200159H, PZN200160H, PZN200162H thru PZN200208H, PZN200210H thru PZN200275H, PZN200277H thru PZN200335H, PZN200337H, PZN200338H, PZN200339H, PZN200340H, PZN200341H, PZN200342H, PZN200343H, PZN200344H, PZN200345H, PZN200346H, PZN200348H, PZN200349H, PZN200350H, PZN200351H, PZN200352H, PZN200353H, PZN200354H, PZN200355H, PZN200356H, PZN200357H, PZN200358H, PZN200359H, PZN200360H, PZN200361H, PZN200362H, PZN200363H, PZN200364H, PZN200365H, PZN200366H, PZN200368H, PZN200369H, PZN200370H, PZN200371H, PZN200372H, PZN200373H, PZN200374H, PZN200375H, PZN200377H thru PZN200434H, PZN200436H thru PZN200450H, PZN200452H, PZN200453H, PZN200454H, PZN200455H, PZN200456H, PZN200457H, PZN200458H, PZN200459H, PZN200460H, PZN200461H, PZN200462H, PZN200463H, PZN200465H thru PZN200536H, PZN200538H thru PZN200569H, PZN200571H thru PZN200582H, PZN200584H thru PZN200628H, PZN200630H thru PZN200682H, PZN200684H thru PZN200763H, PZN200765H, PZN200766H, PZN200767H, PZN200768H, PZN200769H, PZN200770H, PZN200771H, PZN200772H, PZN200773H, PZN200775H thru PZN200855H, PZN200857H thru PZN200936H, PZN200938H thru PZN201009H, PZN201011H thru PZN201171H, PZN201173H thru PZN201229H, PZN201232H, PZN201233H, PZN201234H, PZN201235H, PZN201236H, PZN201237H, PZN201238H, PZN201239H, PZN201240H, PZN201242H, PZN201243H, PZN201244H, PZN201245H, PZN201246H, PZN201247H, PZN201248H, PZN201249H, PZN201250H, PZN201251H, PZN201252H, PZN201253H, PZN201254H, PZN201255H, PZN201256H, PZN201257H, PZN201258H, PZN201260H, PZN201261H, PZN201262H, PZN201263H, PZN201264H, PZN201265H, PZN201266H, PZN201267H, PZN201268H, PZN201269H, PZN201270H, PZN201272H thru PZN201690H, PZN201692H thru PZN201778H, PZN201781H, PZN201782H, PZN201783H, PZN201784H, PZN201786H thru PZN201827H, PZN201829H thru PZN201912H, PZN201914H thru PZN201934H, PZN201936H thru PZN201967H, PZN201969H thru PZN202085H, PZN202087H thru PZN202225H, PZN202227H thru PZN202269H, PZN202271H thru PZN202358H, PZN202360H thru PZN202434H, PZN202436H thru PZN202565H, PZN202567H thru PZN202624H, PZN202626H thru PZN202641H, PZN202643H, PZN202644H, PZN202645H, PZN202646H, PZN202647H, PZN202648H, PZN202649H, PZN202650H, PZN202651H, PZN202652H, PZN202653H, PZN202654H, PZN202655H, PZN202657H thru PZN202720H, PZN202722H thru PZN202732H, PZN202734H thru PZN202895H, PZN202897H thru PZN202945H, PZN202947H thru PZN202967H, PZN202971H, PZN202973H, PZN202974H, PZN202975H, PZN202976H, PZN202977H, PZN202978H, PZN202979H, PZN202980H, PZN202981H, PZN202982H, PZN202984H, PZN202985H, PZN202986H, PZN202987H, PZN202988H, PZN202989H, PZN202990H, PZN202991H, PZN202992H, PZN202993H, PZN202994H, PZN202995H, PZN202996H, PZN202998H thru PZN203024H, PZN203026H thru PZN203077H, PZN203079H thru PZN203152H, PZN203154H thru PZN203197H, PZN203199H thru PZN203228H, PZN203230H, PZN203231H, PZN203232H, PZN203233H, PZN203234H, PZN203235H, PZN203236H, PZN203238H thru PZN203392H, PZN203394H thru PZN203457H, PZN203459H thru PZN203585H, PZN203587H thru PZN203713H, PZN203715H thru PZN203802H, PZN203804H thru PZN203820H, PZN203822H, PZN203823H, PZN203824H, PZN203825H, PZN203826H, PZN203827H, PZN203828H, PZN203829H, PZN203830H, PZN203831H, PZN203834H, PZN203835H, PZN203836H, PZN203837H, PZN203838H, PZN203839H, PZN203841H, PZN203842H, PZN203843H, PZN203844H, PZN203845H, PZN203846H, PZN203847H, PZN203848H, PZN203849H, PZN203850H, PZN203851H, PZN203852H, PZN203853H, PZN203854H, PZN203855H, PZN203856H, PZN203857H, PZN203858H, PZN203859H, PZN203860H, PZN203862H, PZN203863H, PZN203864H, PZN2
Recalling Firm/
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
For Additional Information Contact
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 17834
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 = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT