BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1952022 · Received January 7, 2011

    Report

    Report Number
    2124215-2010-23323
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS EVENT WILL BE UPDATED AND RESUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE DEVICE DELIVERED MULTIPLE INAPPROPRIATE SHOCKS IN RESPONSE TO ATRIAL FIBRILLATION. TACHYCARDIA THERAPY WAS EXHAUSTED. THE PHYSICIAN IS CURRENTLY ATTEMPTING TO RATE CONTROL THIS PATIENT AS PHARMACEUTICAL THERAPY CANNOT BE UTILIZED. THIS DEVICE REMAINS IMPLANTED AND IN SERVICE. NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 4135| E110| 0184