BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 2153318 · Received July 7, 2011

    Report

    Report Number
    2124215-2011-06636
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    March 21, 2011
    Report Date
    April 6, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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 DEVICE DELIVERED INAPPROPRIATE SHOCKS AND ANTI-TACHYCARDIA PACING (ATP) FOR A RHYTHM THAT WAS NOTED TO BE SINUS TACHYCARDIA WHILE THE PATIENT WAS PLAYING BASKETBALL. IT WAS NOTED THAT THE PATIENTS VENTRICULAR TACHYCARDIA (VT-1) ZONE WAS A MONITOR ONLY ZONE, THUS IT WAS QUESTIONED WHY THERAPY WAS PROVIDED. TECHNICAL SERVICES DISCUSSED WHY THE PATIENT RECEIVED THERAPY AND RECOMMENDED PROGRAMMING OPTIONS. THE DEVICE WAS REPROGRAMMED. NO ADVERSE PATIENT EFFECTS REPORTED. THE DEVICE REMAINS IN SERVICE.

    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
    1 269 MO 0181| E102