BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TELIGEN

    MDR report key: 3211645 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08345
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 12, 2013
    Report Date
    October 8, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MEMORY DUMP NOTED THAT SEVERAL EPISODES WERE RECORDED WITH THERAPY DELIVERED DUE TO SEVERAL NON SUSTAINED EPISODES, WHILE SOME WERE UNDERSENSED. TECHNICAL SERVICES SUSPECTED THAT ENERGY EQUIPMENT MAY HAVE CAUSED THE NOISE. NO RESETS WERE NORMAL OR OTHER ABNORMAL FAULTS. POSSIBLE CHANGES TO THE SENSITIVITY MAYBE HAVE IMPROVED VENTRICULAR SENSING. AT THIS TIME THE DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    UPON ADDITIONAL INFORMATION THIS INVESTIGATION WILL BE UPDATED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAD A VENTRICULAR ARRHYTHMIA. UPON INTERROGATION IT WAS NOTED THAT THE DEVICE DETECTED THE ARRHYTHMIA BUT DUE VERY LOW SENSING PROGRAMMED THE DEVICE UNDERSENSED THE ARRHYTHMIA. THE PATIENT EXPERIENCED SYNCOPE AND WAS FOUND IN VENTRICULAR FIBRILLATION IN THE AMBULANCE. THE PATIENT IS CURRENTLY HOSPITALIZED AND A MEMORY DUMP WILL BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310926 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F110

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| O