Medtronic Maximo DR, model 7278 Single Chamber Implantable Cardioverter Defibrillator (ICD)devices are tiered therapy implantable arrhythmia control devices, which provide automatic detection of ventricular arrhythmias and delivery of user-selected therapies for the detected arrhythmia. Therapies are automatically delivered following detection or can be initiated via programming by the physician. These ICDs are multi-programmable and have the capability of transmitting via telemetry the programmed values, measured and collected data, and event markers.
FDA Recall Z-0601-05 · Posted 2005-03-11
Advertisement
Recalling FirmMedtronic Inc. Cardiac Rhythm Managment
Recall StatusTerminated
Product CodeLWS
Date Initiated2005-02-09
Date Terminated2006-12-28
Product Quantity2,542 total, (2,217 in US & 325 OUS)
Reason for Recall
Medtronic marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery short mechanism. Once a short occurs, depletion can take place within a few hours to a few days, after which there is a complete loss of device function.
Firm Action
Medtronic Sales Representatives contacted affected physicians starting 02/10/05 to deliver an Important Patient Management Information. The letter recommended patient managment options including quarterly follow-ups, programming Patient Alert to 'On-High', provide magnet to patients to check device status and inform patients that should they expereicnce warmth in the area surrounding the ICD to seek prompt care.
Root Cause
Other
Distribution Pattern
worldwide
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement