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U.S. Department of Health and Human Services

Class 2 Device Recall Maximo II CRTD

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 Class 2 Device Recall Maximo II CRTD see related information
Date Posted October 21, 2010
Recall Status1 Terminated on March 15, 2012
Recall Number Z-0112-2011
Recall Event ID 55922
PMA Number P010031S084 
Product Classification Defirbillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d) - Product Code NIK
Product Medtronic Maximo II CRT-D, model D284TRK. Digital implantable cardioverter defibrillator with cardiac resynchronization therapy (VVE-DDDR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA.
The Dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT-D) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, sequential biventricular 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). Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device responds to bradyarrhythmias by providing bradycardia pacing therapies.
Code Information thru PZP206078H, PZP206080H, thru PZP206108H, PZP206110H, thru PZP206161H, PZP206163H thru PZP206193H, PZP206195H thru PZP206245H, PZP206249H, PZP206251H thru PZP206354H, PZP206356H thru PZP206430H, PZP206432H thru PZP206618H, PZP206620H thru PZP206663H, PZP206665H thru PZP206713H, PZP206716H PZP206859H thru PZP207074H, PZP207076H thru PZP207093H, PZP207095H thru PZP207147H, PZP207149H thru PZP207214H, PZP207216H thru PZP207255H, PZP207257H thru PZP207284H, PZP207286H thru PZP207381H, PZP207383H thru PZP207405H, PZP207407H, PZP207409H, PZP207410H, PZP207411H, PZP207412H, PZP207413H, PZP207415H thru PZP207621H, PZP207623H thru PZP207674H, PZP207676H thru PZP207823H, PZP207826H thru PZP208195H, PZP208197H, PZP208198H thru PZP208218H, PZP208220H thru PZP208362H, PZP208364H thru PZP208420H, PZP208422H, PZP208424H thru PZP208465H, PZP208467H thru PZP208878H, PZP208880H thru PZP208921H, PZP208923H thru PZP208970H, PZP208972H thru PZP209136H, PZP209138H thru PZP209219H, PZP209221H thru PZP209257H, PZP209259H thru PZP209585H, PZP209588H thru PZP209730H, PZP209732H thru PZP209750H, PZP209752H thru PZP209768H, PZP209770H thru PZP209804H, PZP209807H thru PZP209886H, PZP209888H, PZP209891H thru PZP209933H, PZP209935H thru PZP209977H, PZP209979H thru PZP210069H, PZP600001S, PZP600002S, PZP600003S, PZP600004S, PZP600005S, PZP600006S, PZP600087S thru PZP600180S, PZP600182S, PZP600183S, PZP600184S, PZP600185S, PZP600186S, PZP600187S, PZP600188S, PZP600190S, PZP600191S, PZP600192S, PZP600193S, PZP600194S, PZP600195S, PZP600196S, PZP600197S, PZP600198S, PZP600199S, PZP600200S, PZP600202S thru PZP600219S, PZP600221S thru PZP600278S, PZP600280S, PZP600281S, PZP600282S, PZP600283S, PZP600284S, PZP600285S, PZP600286S, PZP600287S, PZP600289S, PZP600291S, PZP600292S, PZP600293S, PZP600295S thru PZP600313S, PZP600318S, PZP600319S, PZP600320S, PZP600323S, PZP600324S, PZP600325S, PZP600326S, PZP600327S, PZP600328S, PZP600331S, PZP600334S, PZP600335S, PZP600336S, PZP600338S, PZP600339S, PZP600340S, PZP600341S, PZP600342S, PZP600343S, PZP600345S, PZP600346S, PZP600347S, PZP600348S, PZP600350S thru PZP600394S, PZP600396S, PZP600397S, PZP600398S, PZP600399S, PZP600401S thru PZP600421S, PZP600423S, PZP600424S, PZP600425S, PZP600426S, PZP600427S, PZP600429S, PZP600430S, PZP600431S, PZP600432S, PZP600433S, PZP600434S, PZP600435S, PZP600436S, PZP600437S, PZP600438S, PZP600439S, PZP600440S, PZP600442S, PZP600443S, PZP600444S, PZP600448S, PZP600450S, PZP600452S, PZP600453S, PZP600454S, PZP600455S, PZP600456S, PZP600457S, PZP600458S, PZP600459S, PZP600462S thru PZP600618S, PZP600620S thru PZP600676S, PZP600678S thru PZP600729S, PZP600731S thru PZP600740S, PZP600742S, PZP600743S, PZP600745S thru PZP600795S, PZP600797S, PZP600798S, PZP600799S, PZP600800S, PZP600801S, PZP600802S, PZP600803S, PZP600804S, PZP600806S, PZP600807S, PZP600808S, PZP600809S, PZP600810S, PZP600811S, PZP600813S thru PZP600884, PZP600888S thru PZP601107S, PZP601109S thru PZP601127S, PZP601129S thru PZP601149S, PZP601152S thru PZP601165S, PZP601167S thru PZP601289S, PZP601291S thru PZP601340S, PZP601342S thru PZP601363S, PZP601365S, PZP601366S, PZP601367S, PZP601368S, PZP601369S, PZP601371S, PZP601372S, PZP601373S, PZP601375S, PZP601376S, PZP601377S, PZP601378S, PZP601379S, PZP601380S, PZP601381S, PZP601383S, PZP601384S, PZP601385S, PZP601387S thru PZP601423S, PZP601425S thru PZP601648S, PZP601650S thru PZP601825S, PZP601827S thru PZP601879S, PZP601881S thru PZP602022S, PZP602024S thru PZP602139S, PZP602141S thru PZP602196S, PZP602198S thru PZP602309S, PZP602311S thru PZP602426S, PZP602428S thru PZP602631S, PZP602633S thru PZP602723S, PZP602725S thru PZP602743S, PZP602745S, PZP602746S, PZP602747S, PZP602748S, PZP602749S, PZP602751S thru PZP602971S, PZP602973S, PZP602974S, PZP602975S, PZP602976S, PZP602977S, PZP602978S, PZP602979S, PZP602981S thru PZP602998S, PZP603000S thru PZP603406S, PZP603408S thru PZP603537S, PZP603539S thru PZP603587S, PZP603589S thru PZP603654S, PZP603656S, PZP603657S, PZ
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 16910
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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