BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0801-05 · Initiated January 25, 2005

    Recall

    Recall Number
    Z-0801-05
    Event Number
    31539
    Firm
    ela Medical Llc
    FEI Number
    2182863
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 25, 2005
    Posted
    May 6, 2005
    Terminated
    July 22, 2006
    Address
    2950 Xenium Ln N, Ste 120, Plymouth, MN, 55441-2623

    Description

    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.

    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.

    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.

    Distribution

    AZ, CA, GA, IL, IN, KY, MA, MD, MI, MN, NC, NJ, OH, PA and to UK, Italy, Germany and Argentina.

    Quantity

    38 in US and 47 OUS