BEUDAMED
    FDA Enforcement Class II Terminated

    Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.

    Recall: Z-1979-2013 · Reported August 28, 2013

    Enforcement

    Recall Number
    Z-1979-2013
    Event ID
    65798
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Boston Scientific CRM Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 28, 2013
    Initiation Date
    July 15, 2013
    Classification Date
    August 16, 2013
    Termination Date
    November 12, 2013
    Address
    4100 Hamline Ave N, N/A, Saint Paul, MN, 55112-5700, United States

    Description

    Boston Scientific, ENERGEN DR ICD, Model E143. The device is an Implantable Cardioverter Defibrillator.

    Reason

    Boston Scientific CRM manufacturing quality system recently discovered test artifacts (related to shock charge time) in a small number of implantable defibrillators (ENERGEN DR ICD model E143) which require further investigation. While these devices successfully passed all manufacturing tests and met all requirements, they showed a slightly longer charge time than other devices during a manufactu

    Code Info

    Serial # 108063

    Distribution

    US distribution in the state of Tennessee.

    Quantity

    1 (4 devices were implanted and are not part of this action)