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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 ZM600609S
PZM600488S
PZM600489S
PZM600261S
PZM600263S
PZM600641S
PZM600642S
PZM600270S
PZM600516S
PZM600589S
PZM600592S
PZM600255S
PZM600249S
PZM600169S
PZM600172S
PZM600174S
PZM600175S
PZM600176S
PZM600177S
PZM600178S
PZM600179S
PZM600181S
PZM600182S
PZM600183S
PZM600187S
PZM600191S
PZM600246S
PZM600474S
PZM600644S
PZM600507S
PZM600543S
PZM600250S
PZM600244S
PZM600534S
PZM600548S
PZM600549S
PZM600537S
PZM600538S
PZM600552S
PZM600553S
PZM600185S
PZM600188S
PZM600521S
PZM600522S
PZM600271S
PZM600527S
PZM600607S
PZM600627S
PZM600555S
PZM600646S
PZM600294S
PZM600295S
PZM600511S
PZM600713S
PZM600714S
PZM600260S
PZM600524S
PZM600525S
PZM600554S
PZM600268S
PZM600269S
PZM600475S
PZM600476S
PZM600477S
PZM600214S
PZM600541S
PZM600210S
PZM600212S
PZM600520S
PZM600540S
PZM600114S
PZM600115S
PZM600226S
PZM600229S
PZM600230S
PZM600483S
PZM600484S
PZM600485S
PZM600529S
PZM600205S
PZM600572S
PZM600575S
PZM600267S
PZM600106S
PZM600164S
PZM600103S
and PZM600645S.
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 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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