BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2911299 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15956
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 26, 2012
    Report Date
    November 28, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 THIS PATIENT HAD AN EVENT IN MONITOR ZONE IN WHICH THE INITIAL DETECTION AND DURATION WERE MET. THE RHYTHM ACCELERATED TO VENTRICULAR TACHYCARDIA (VT) ZONE. THE DEVICE WENT TO REDETECTION AND DELIVERED TWO ANTI-TACHYCARDIA PACING (ATP) WHICH RESULTED IN ATP TIMEOUT AND THE PATIENT RECEIVED A SHOCK. AS A RESULT, THE DEVICE WAS REPROGRAMMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16346 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F102

    Patients

    Seq Age Sex Outcome Treatment
    1