Medtronic Marquis VR, model 7230 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 progr
Hazard
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.
What You Should Do
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.
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Products
- Brand
- Medtronic Inc. Cardiac Rhythm Managment
- UPC
- Model 7230 Marquis VR (serial numbers listed include all affected devices but may include some unaffected devices. Patients are recommended to check with their doctor for exact serial numbers affected.) 7230B S-Series: PLW600001S - PLW600646S. 7230Cx H-Series: PKD100001H - PKD116584H, PKD117397H, PKD117553H, PKD117735H, and PKD117741H. R-Series: PKD200084R - PKD200536R, PKD600016R - PKD600113R. S-Series: PKD600009S - PKD608391S. 7230E S-Series: PLY600001S - PLY600749S and PLY600839S.
Units Affected
21,926 total, (13,508 in US & 8,418 OUS)