BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3043193 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02232
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    January 25, 2013
    Report Date
    January 25, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT EXPERIENCED SIX INAPPROPRIATE ANTI-TACHYCARDIA PACING (ATP) EPISODES AND FOUR SHOCKS DUE TO THE RHYTHM ID BECOMING UNCORRELATED. THERAPY WAS EXHAUSTED.IT WAS ALSO NOTED THAT NOISE WAS SEEN ON THE SHOCK CHANNEL AT THE BEGINNING OF THE EPISODE, BUT NOT LEADING UP TO THE THERAPY. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THAT SINCE THE PATIENT TYPICALLY HAS HIGH STABLE HEART RATES, THERE WERE NO GOOD REPROGRAMMING OPTIONS. THE DEVICE WAS REPROGRAMMED TO GIVE THERAPY IN THE VENTRICULAR FIBRILLATION (VF) ZONE ONLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146508 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR E102| 0185