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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Maximo II DR

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 Class 2 Device Recall Medtronic Maximo II DR see related information
Date Posted January 28, 2009
Recall Status1 Terminated on May 07, 2011
Recall Number Z-0665-2009
Recall Event ID 50137
PMA Number P980016 
Product Classification implantable pacemaker defibrillator - Product Code LWS
Product Medtronic Maximo II DR D28DRG, for ventricular pacing and defibrillation.
Code Information Lot Serial No
PZM600131S
PZM600054S
PZM600616S
PZM600617S
PZM600620S
PZM600615S
PZM600523S
PZM600111S
PZM600213S
PZM600502S
PZM600595S
PZM600600S
PZM600277S
PZM600078S
PZM600581S
PZM600582S
PZM600597S
PZM600602S
PZM600530S
PZM600108S
PZM600495S
PZM600497S
PZM600498S
PZM600500S
PZM600501S
PZM600151S
PZM600152S
PZM600153S
PZM600446S
PZM600447S
PZM600448S
PZM600264S
PZM600278S
PZM600469S
PZM600094S
PZM600401S
PZM600052S
PZM600053S
PZM600517S
PZM600621S
PZM600622S
PZM600233S
PZM600539S
PZM600129S
PZM600130S
PZM600132S
PZM600160S
PZM600162S
PZM600207S
PZM600208S
PZM600138S
PZM600140S
PZM600145S
PZM600146S
PZM600148S
PZM600156S
PZM600198S
PZM600056S
PZM600092S
PZM600104S
PZM600105S
PZM600147S
PZM600168S
PZM600252S
PZM600051S
PZM600199S
PZM600057S
PZM600273S
PZM600075S
PZM600232S
PZM600472S
PZM600049S
PZM600203S
PZM600276S
PZM600071S
PZM600143S
PZM600098S
PZM600110S
PZM600167S
PZM600101S
PZM600109S
PZM600126S
PZM600150S
PZM600491S
PZM600492S
PZM600080S
PZM600081S
PZM600281S
PZM600282S
PZM600283S
PZM600284S
PZM600285S
PZM600286S
PZM600287S
PZM600288S
PZM600289S
PZM600290S
PZM600184S
PZM600192S
PZM600245S
PZM600180S
PZM600262S
PZM600526S
PZM600643S
PZM600473S
PZM600186S
PZM600189S
PZM600243S
PZM600266S
PZM600247S
PZM600254S
PZM600556S
PZM600557S
PZM600558S
PZM600559S
PZM600560S
PZM600561S
PZM600562S
PZM600563S
PZM600584S
PZM600586S
PZM600112S
PZM600544S
PZM600599S
PZM600486S
PZM600405S
PZM600406S
PZM600407S
PZM600408S
PZM600409S
PZM600410S
PZM600411S
PZM600412S
PZM600413S
PZM600414S
PZM600415S
PZM600416S
PZM600417S
PZM600418S
PZM600419S
PZM600420S
PZM600421S
PZM600422S
PZM600423S
PZM600424S
PZM600425S
PZM600426S
PZM600427S
PZM600428S
PZM600429S
PZM600430S
PZM600431S
PZM600432S
PZM600433S
PZM600434S
PZM600435S
PZM600436S
PZM600437S
PZM600438S
PZM600439S
PZM600440S
PZM600441S
PZM600442S
PZM600443S
PZM600444S
PZM600445S
PZM600059S
PZM600060S
PZM600061S
PZM600062S
PZM600063S
PZM600064S
PZM600065S
PZM600066S
PZM600135S
PZM600136S
PZM600137S
PZM600116S
PZM600117S
PZM600118S
PZM600119S
PZM600120S
PZM600121S
PZM600122S
PZM600123S
PZM600124S
PZM600125S
PZM600079S
PZM600206S
PZM600578S
PZM600215S
PZM600216S
PZM600217S
PZM600218S
PZM600219S
PZM600220S
PZM600221S
PZM600222S
PZM600223S
PZM600224S
PZM600265S
PZM600083S
PZM600470S
PZM600528S
PZM600533S
PZM600640S
PZM600577S
PZM600076S
PZM600594S
PZM600241S
PZM600242S
PZM600272S
PZM600274S
PZM600573S
PZM600574S
PZM600576S
PZM600161S
PZM600163S
PZM600234S
PZM600133S
PZM600134S
PZM600193S
PZM600194S
PZM600090S
PZM600509S
PZM600072S
PZM600142S
PZM600173S
PZM600623S
PZM600624S
PZM600482S
PZM600196S
PZM600197S
PZM600535S
PZM600536S
PZM600067S
PZM600068S
PZM600077S
PZM600490S
PZM600190S
PZM600611S
PZM600612S
PZM600084S
PZM600087S
PZM600088S
PZM600089S
PZM600231S
PZM600201S
PZM600202S
PZM600141S
PZM600471S
PZM600546S
PZM600235S
PZM600236S
PZM600048S
PZM600128S
PZM600550S
PZM600551S
PZM600073S
PZM600085S
PZM600055S
PZM600158S
PZM600251S
PZM600165S
PZM600280S
PZM600070S
PZM600170S
PZM600204S
PZM600097S
PZM600545S
PZM600058S
PZM600166S
PZM600587S
PZM600512S
PZM600513S
PZM600291S
PZM600292S
PZM600293S
PZM600107S
PZM600510S
PZM600050S
PZM600149S
PZM600102S
PZM600238S
PZM600240S
PZM600598S
PZM600601S
PZM600086S
PZM600091S
PZM600596S
PZM600099S
PZM600100S
PZM600093S
PZM600155S
PZM600157S
PZM600159S
PZM600253S
PZM600171S
PZM600590S
PZM600493S
PZM600074S
PZM600209S
PZM600580S
PZM600494S
PZM600069S
PZM600200S
PZM600144S
PZM600154S
PZM600047S
PZM600095S
PZM600275S
PZM600547S
PZM600225S
PZM600113S
PZM600613S
PZM600614S
PZM600542S
PZM600237S
PZM600402S
PZM600403S
PZM600404S
PZM600514S
PZM600515S
PZM600258S
PZM600259S
PZM600487S
PZM600248S
PZM600279S
PZM600508S
PZM600256S
PZM600257S
PZM600608S
P
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment
8200 Coral Sea St Ne
Mounds View MN 55112-4391
For Additional Information Contact
763-526-0000
Manufacturer Reason
for Recall
Maximo II VR ICD, DR ICD and CRT-D inadvertently include the Capture Management algorithm (Atrial/Right Ventricular/Left Ventricular Capture management). The Capture management algorithm monitors daily pacing thresholds and may increase or decrease pacing amplitudes in response to patients' needs. Although the algorithm is operating correctly, it is not accessible to the clinician for reprogramm
FDA Determined
Cause 2
Process design
Action A Medtronic Inc. letter dated July 30, 2008 was sent to Physicians. The letter described the product and problem. The letter advised to contact Technical Services for specific questions regarding the care of patients or how to program the Maximo II devices. The letter instructed to collect and hold all non-implanted Maximo II devices and that a Medtronic Representative will contact the doctor to make arrangements to update the programmer 2090.
Quantity in Commerce 419
Distribution No US distribution. OUS to include: AUSTRIA, DENMARK, FINLAND, GERMANY, ITALY, SPAIN, SWEDEN, UK, GREECE, HONG KONG, INDIA, JORDAN, and SAUDI ARABIA.
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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