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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 Device Recall Medtronic Maximo II VR see related information
Date Posted January 28, 2009
Recall Status1 Terminated on May 07, 2011
Recall Number Z-0666-2009
Recall Event ID 50137
PMA Number P980016 
Product Classification implantable pacemaker defibrillator - Product Code LWS
Product Medtronic Maximo II VR D284VRC, for ventricular pacing and defibrillation.
Code Information Lot Serial No
PZN600430S
PZN600431S
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PZN600428S
PZN600422S
PZN600385S
PZN600317S
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PZN600462S
PZN600419S
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PZN600129S
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PZN600330S
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PZN600463S
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PZN600101S
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PZN600302S
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PZN600215S
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PZN600119S
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PZN600051S
PZN600265S
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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
P
Recalling Firm/
Manufacturer
Medtronic Inc. Cardiac Rhythm Managment
8200 Coral Sea St Ne
Mounds View MN 55112-4391
763-514-4000
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 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 Original Applicant = MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
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