Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2012 is a multi-programmable, two-zone, tiered-therapy device that incorporates anti-tachycardia pacing (ATP), cardioversion, and defibrillation (DEF) tachyarrhythmia therapies. The device also includes a programmable Hot Can electrode and bradycardia pacing support.
- Company
- Ela Medical Llc
- Recall Initiated
- January 25, 2005
- Posted
- May 6, 2005
- Terminated
- July 22, 2006
- Recall Number
- Z-0802-05
- Quantity
- 3 in US and 2 OUS
- Firm Location
- Plymouth, MN
Reason for Recall
A change in the automatic capacitor reform schedule during the later portion of the device's useful life can result in excessive 750V charge times and disable the device's ability to report an End of Life (EOL) indicator due to excessive charge times unless the patient is receiving periodic 750V therapy shocks.
Distribution
AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.
Lot / Code Info
BE650129, BE650026 and BE650027. OUS: BE650038 and BE650002
Root Cause
Other
Action Taken
Angeion notified physicians responsible for managing each remaining implanted ICD, also provided them with programming means to change the automatic cap charging schedule, and to monitor and document the reprogramming process.
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