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U.S. Department of Health and Human Services

Class 2 Device Recall Maximo II DR

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 Class 2 Device Recall Maximo II DR see related information
Date Posted October 21, 2010
Recall Status1 Terminated on March 15, 2012
Recall Number Z-0113-2011
Recall Event ID 55922
PMA Number P980016S114 
Product Classification Implantable cardioverter defibrillator (non-crt) - Product Code LWS
Product Medtronic Maximo II DR, model D284DRG. Digital dual chamber implantable cardioverter defibrillator (VVE-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, and ventricular 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). The device responds to bradyarrhythmias by providing bradycardia pacing therapies.
Code Information PZM205249H thru PZM205468H, PZM205470H, PZM205471H, PZM205472H, PZM205473H, PZM205474H, PZM205475H, PZM205476H, PZM205477H, PZM205478H, PZM205480H thru PZM205623H, PZM205625H thru PZM205638H, PZM205640H thru PZM205919H, PZM205921H, PZM205922H, PZM205923H, PZM205924H, PZM205926H thru PZM206030H, PZM206032H, PZM206033H thru PZM206077H, PZM206079H thru PZM206090H, PZM206092H thru PZM206105H, PZM206107H thru PZM206151H, PZM206153H thru PZM206210H, PZM206212H thru PZM206539H, PZM206541H thru PZM206799H, PZM206801H thru PZM206848H, PZM206850H thru PZM206907H, PZM206909Hthru PZM206918H, PZM206920H thru PZM206961H, PZM206963H thru PZM207106H, PZM207108H thru PZM207232H, PZM207234H thru PZM207276H, PZM207278H thru PZM207339H, PZM207341H thu PZM207428H, PZM207430H thru PZM207441H, PZM207443H thru PZM207564H, PZM207566H thru PZM207676H, PZM207678H thru PZM207693H, PZM207695H thru PZM207704H, PZM207706H thru PZM207805H, PZM207807H thru PZM207986H, PZM207988H thru PZM208082H, PZM208084H thru PZM208104H, PZM208106H thru PZM208143H PZM208145 thru PZM208151H, PZM208153H thru PZM208164H, PZM208166H, thru PZM208175H, PZM208177H thru PZM208189H, PZM208191H thru PZM208275H, PZM208277H thru PZM208371H, PZM208373H thru PZM208450H, PZM208452H thru PZM208563H, PZM208565H thru PZM208633H, PZM208635H thru PZM208780H, PZM208782H thru PZM209153H, PZM209155H thru PZM209250H, PZM209252H thru PZM209264H, PZM209266H thru PZM209282H, PZM209284H, PZM209285H, PZM209286H, PZM209287H, PZM209289H thru PZM209348H, PZM209350H thru PZM209382H, PZM209384H thru PZM209427H, PZM209429H thru PZM209496H, PZM209498H thru PZM209512H, PZM209514H, PZM209517H, thru PZM209568H, PZM209570H thru PZM209658H, PZM209660H, PZM209661H, PZM209662H, PZM209663H, PZM209664H, PZM209666H thru PZM209819H, PZM209821H thru PZM209878H, PZM209880H thru PZM209908H, PZM209910H thru PZM209935H, PZM209937H, PZM209940H thru PZM209962H, PZM209964H thru PZM210010H, PZM210012H thru PZM210037H, PZM210039H thru PZM210404H, PZM210406H thru PZM210462H, PZM210464H thru PZM210505H, PZM210507H thru PZM210569H, PZM210571H thru PZM210606H, PZM210608H thru PZM210779H, PZM210781H thru PZM210837H, PZM210839H, PZM210840H, PZM210841H, PZM210843H, PZM210844H, PZM210845H, PZM210846H, PZM210847H, PZM210848H, PZM210849H, PZM210850H, PZM210852H thru PZM210903H, PZM210905H thru PZM210914H, PZM210916H thru PZM210956H, PZM210958H thru PZM211011H, PZM211013H thru PZM211038H, PZM211040H thru PZM211129H, PZM211131H, PZM211133H thru PZM211165H, PZM211167H thru PZM211254H, PZM211256H thru PZM211348H, PZM211350H thru PZM211414H, PZM211416H thru PZM211427H, PZM211429H thru PZM211521H, PZM211523H thru PZM211542H, PZM211544H thru PZM211710H, PZM211712H thru PZM211863H, PZM211865H thru PZM211953H, PZM211955H thru PZM212023H, PZM212025H thru PZM212157H, PZM212159H thru PZM212210H, PZM212212H thru PZM212278H, PZM212280H thru PZM212298H, PZM212300H, PZM212301H, PZM212302H, PZM212303H, PZM212304H, PZM212305H, PZM212307H thru PZM212324H, PZM212326H thru PZM212455H, PZM212456H, PZM212457H thru PZM212502H, PZM212504H thru PZM212541H, PZM212543H, PZM212545H, PZM212547H thru PZM212561H, PZM212564H, PZM212565H, PZM212566H, PZM212567H, PZM212568H, PZM212569H, PZM212570H, PZM212571H, PZM212572H, PZM212573H, PZM212574H, PZM212575H, PZM212576H, PZM212578H thru PZM212604H, PZM212606H thru PZM212624H, PZM212626H thru PZM212640H, PZM212642H thru PZM212703H, PZM212704H, PZM212705H, PZM212706H, PZM212707H, PZM212709H thru PZM212737H, PZM212739H, PZM212741H thru PZM212785H, PZM212787H, PZM212788H thru PZM212840H, PZM212843H, PZM212844H, PZM212845H, PZM212847H, PZM212848H, PZM212849H, PZM212850H, PZM212851H, PZM212852H, PZM212853H thru PZM212947H, PZM212949H thru PZM213085H, PZM213088H, PZM213091H thru PZM213106H, PZM213108H thru PZM213201H, PZM600001S thru PZM600047S, PZM600048S thru PZM600095S, PZM600097S thru PZM600126S, PZM600128S thru PZM600138S, PZM600140S thru PZM600194S, PZM600196S thru PZM600238S, PZM600240S thru PZM600295S, PZM600297S, PZM600
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Disease Managment
8200 Coral Sea St. N.E.
Saint Paul MN 55112
763-514-4000
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 20421
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 = LWS and Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
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