BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1860504 · Received October 7, 2010

    Report

    Report Number
    2124215-2010-14955
    Event Type
    Malfunction
    Date Received
    October 7, 2010
    Date of Event
    January 11, 2010
    Report Date
    July 23, 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

    AS OF TODAY, THE DEVICE REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS DEVICE HAD A RAPIDLY CONDUCTING ATRIAL FIBRILLATION WHICH RESULTED IN INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) TO BE DELIVERED. THE ATP ACCELERATED THE RHYTHM FOR WHICH INAPPROPRIATE SHOCKS WERE DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR 7000| 6947| E102| 0184