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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 298S thru PZM600321S, PZM600324S, PZM600328S, PZM600333S, PZM600336S, PZM600340S, PZM600343S, PZM600345S, PZM600348S, PZM600350S, PZM600352S, PZM600354S, PZM600355S, PZM600357S, PZM600358S, PZM600359S, PZM600364S, PZM600365S, PZM600368S, PZM600370S, PZM600373S, PZM600376S, PZM600385S, PZM600388S, PZM600390S, PZM600391S, PZM600392S, PZM600396S, PZM600397S, PZM600401S thru PZM600495S, PZM600497S, PZM600498S, PZM600500S thru PZM600563S, PZM600565S thru PZM600582S, PZM600584S thru PZM600604S, PZM600606S thru PZM600676S, PZM600678S, PZM600679S, PZM600680S, PZM600682S, PZM600683S thru PZM600728S, PZM600730S thru PZM600805S, PZM600807S, PZM600808S, PZM600809S, PZM600810S, PZM600811S, PZM600812S, PZM600813S, PZM600814S, PZM600816S thru PZM600837S, PZM600839S thru PZM600882S, PZM600884S thru PZM600907S, PZM600909S thru PZM601026S, PZM601028S thru PZM601040S, PZM601042S thru PZM601088S, PZM601090S thru PZM601248S, PZM601250S thru PZM601466S, PZM601468S thru PZM601523S, PZM601525S thru PZM601545S, PZM601547S thru PZM601592S, PZM601594S thru PZM601786S, PZM601788S, PZM601789S, PZM601790S, PZM601792S, PZM601793S, PZM601794S thru PZM601936S, PZM601938S thru PZM602099S, PZM602101S thru PZM602142S, PZM602144S, PZM602167S thru PZM602355S, PZM602357S thru PZM602445S, PZM602447S thru PZM603113S, PZM603115S thru PZM603339S, PZM603341S thru PZM603460S, PZM603462S thru PZM603525S, PZM603527S thru PZM603730S, PZM603732S thru PZM603845S, PZM603847S thru PZM603930S, PZM603932S, PZM603933S, PZM603934S, PZM603935S, PZM603937S thru PZM604046S, PZM604048S, PZM604049S thru PZM604104S, PZM604106S thru PZM604185S, PZM604187S thru PZM604197S, PZM604199S thru PZM604337S, PZM604339S thru PZM604399S, PZM604401S, PZM604402S, PZM604403S, PZM604404S, PZM604405S, PZM604406S, PZM604407S, PZM604408S, PZM604409S, PZM604410S, PZM604411S, PZM604413S thru PZM604496S, PZM604498S thru PZM604668S, PZM604670S thru PZM604737S, PZM604739S thru PZM605087S, PZM605089S thru PZM605110S, PZM605112S thru PZM605528S, PZM605530S thru PZM605622S, PZM605624S thru PZM605636S, PZM605638S thru PZM605678S, PZM605680S thru PZM605850S, PZM605852S thru PZM606000S, PZM606002S thru PZM606312S, PZM606315S thru PZM606328S, PZM606330S thru PZM606370S, PZM606372S thru PZM606662S, PZM606664S thru PZM606694S, PZM606696S thru PZM606709S, PZM606711S thru PZM607263S, PZM607265S thru PZM607284S, PZM607286S thru PZM607293S, PZM607295S thru PZM607320S, PZM607322S thru PZM607361S, PZM607363S thru PZM607430S, PZM607432S thru PZM607501S, PZM607503S thru PZM607544S, PZM607546S thru PZM607569S, PZM607571S, PZM607572S, PZM607573S, PZM607575S, PZM607577S, PZM607636S.
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 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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