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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Maximo II VR

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 Class 2 Recall
Medtronic Maximo II VR
see related information
Date Posted January 28, 2009
Recall Status1 Open
Recall Number Z-0666-2009
Recall Event ID 50137
Premarket Approval
PMA Number
P980016
Product Classification Implantable Cardioverter Defibrillator (Non-Crt) - Product Code LWS
Product Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation.
Code Information Lot Serial No PZN600430S PZN600431S PZN600436S PZN600428S PZN600422S PZN600385S PZN600317S PZN600383S PZN600308S PZN600418S PZN600388S PZN600409S PZN600410S PZN600250S PZN600391S PZN600392S PZN600374S PZN600375S PZN600116S PZN600333S PZN600334S PZN600335S PZN600336S PZN600337S PZN600145S PZN600146S PZN600147S PZN600148S PZN600348S PZN600349S PZN600057S PZN600058S PZN600351S PZN600352S PZN600247S PZN600248S PZN600328S PZN600462S PZN600419S PZN600199S PZN600200S PZN600129S PZN600130S PZN600131S PZN600132S PZN600134S PZN600151S PZN600152S PZN600153S PZN600154S PZN600167S PZN600181S PZN600182S PZN600201S PZN600208S PZN600209S PZN600210S PZN600211S PZN600212S PZN600213S PZN600214S PZN600249S PZN600325S PZN600326S PZN600327S PZN600329S PZN600330S PZN600362S PZN600381S PZN600463S PZN600464S PZN600082S PZN600083S PZN600084S PZN600085S PZN600086S PZN600071S PZN600088S PZN600149S PZN600138S PZN600079S PZN600429S PZN600442S PZN600101S PZN600135S PZN600140S PZN600183S PZN600111S PZN600067S PZN600361S PZN600074S PZN600055S PZN600107S PZN600143S PZN600170S PZN600171S PZN600266S PZN600169S PZN600341S PZN600254S PZN600255S PZN600256S PZN600257S PZN600258S PZN600259S PZN600260S PZN600261S PZN600262S PZN600263S PZN600197S PZN600237S PZN600239S PZN600219S PZN600246S PZN600236S PZN600203S PZN600227S PZN600252S PZN600164S PZN600202S PZN600396S PZN600397S PZN600398S PZN600399S PZN600400S PZN600401S PZN600402S PZN600403S PZN600404S PZN600405S PZN600425S PZN600426S PZN600427S PZN600196S PZN600318S PZN600195S PZN600354S PZN600316S PZN600127S PZN600123S PZN600313S PZN600312S PZN600268S PZN600269S PZN600270S PZN600271S PZN600272S PZN600273S PZN600274S PZN600275S PZN600276S PZN600277S PZN600278S PZN600060S PZN600061S PZN600062S PZN600063S PZN600064S PZN600574S PZN600136S PZN600137S PZN600359S PZN600547S PZN600251S PZN600370S PZN600372S PZN600114S PZN600117S PZN600184S PZN600185S PZN600186S PZN600187S PZN600188S PZN600189S PZN600190S PZN600191S PZN600307S PZN600103S PZN600379S PZN600380S PZN600087S PZN600407S PZN600408S PZN600180S PZN600363S PZN600364S PZN600365S PZN600366S PZN600414S PZN600415S PZN600465S PZN600466S PZN600467S PZN600133S PZN600166S PZN600100S PZN600075S PZN600340S PZN600115S PZN600434S PZN600435S PZN600320S PZN600168S PZN600068S PZN600069S PZN600324S PZN600078S PZN600423S PZN600094S PZN600420S PZN600097S PZN600098S PZN600099S PZN600122S PZN600090S PZN600091S PZN600175S PZN600176S PZN600141S PZN600303S PZN600304S PZN600389S PZN600206S PZN600207S PZN600049S PZN600050S PZN600053S PZN600054S PZN600128S PZN600424S PZN600073S PZN600095S PZN600076S PZN600077S PZN600059S PZN600080S PZN600139S PZN600155S PZN600302S PZN600350S PZN600105S PZN600106S PZN600215S PZN600216S PZN600546S PZN600144S PZN600118S PZN600119S PZN600120S PZN600052S PZN600437S PZN600438S PZN600439S PZN600112S PZN600113S PZN600440S PZN600441S PZN600096S PZN600241S PZN600109S PZN600110S PZN600102S PZN600065S PZN600072S PZN600331S PZN600066S PZN600081S PZN600413S PZN600421S PZN600332S PZN600070S PZN600172S PZN600173S PZN600142S PZN600433S PZN600048S PZN600108S PZN600104S PZN600056S PZN600125S PZN600386S PZN600051S PZN600265S PZN600217S PZN600267S PZN600345S PZN600346S PZN600231S PZN600232S PZN600321S PZN600223S PZN600339S PZN600229S PZN600230S PZN600305S PZN600306S PZN600322S PZN600323S PZN600235S PZN600369S PZN600245S PZN600347S PZN600406S PZN600228S PZN600432S PZN600156S PZN600157S PZN600158S PZN600159S PZN600161S PZN600163S PZN600165S PZN600218S PZN600220S PZN600221S PZN600222S PZN600198S PZN600360S PZN600238S PZN600338S PZN600240S PZN600224S PZN600226S PZN600367S PZN600390S PZN600377S PZN600378S PZN600393S PZN600394S PZN600160S PZN600162S PZN600355S PZN600356S PZN600357S PZN600358S PZN600204S PZN600205S PZN600371S PZN600395S PZN600469S PZN600387S PZN600264S PZN600342S PZN600628S PZN600629S PZN600233S PZN600368S PZN600243S PZN600244S PZN600353S PZN600382S PZN600314S PZN600315S PZN600319S PZN600384S PZN600416S PZN600192S PZN600193S PZN600311S PZN600417S PZN600443S PZN600194S PZN600309S PZN600310S PZN600124S PZN600126S PZN600289S PZN600344S PZN600343S PZN600373S PZN600178S PZN600179S PZN600242S PZN600376S PZN600089S and PZN600449S.
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment
8200 Coral Sea St Ne
Mounds View, Minnesota 55112-4391
Consumer Instructions Contact the recalling firm for information
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
DESIGN: 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 376
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 Applicant = MEDTRONIC INC.
PMAs with Product Code = LWS and Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = LWS and Applicant = MEDTRONIC INC., CARDIAC RHYTHM DISEASE MANAGEMENT
PMAs with Product Code = LWS and Applicant = MEDTRONIC VASCULAR
PMAs with Product Code = LWS and Applicant = MEDTRONIC, INC.
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