Recall Z-0801-05 ยท LWS Implantable Cardioverter Defibrillator (Non-Crt)
ela Medical Llc
Sentinel Implantable Carioverter-DefibrilIator (ICD) model 2010 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.
| Date | May 6, 2005 (initiated Jan 25, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 38 in US and 47 OUS |
| Distribution | AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.