BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1871486 · Received October 15, 2010

    Report

    Report Number
    2124215-2010-17237
    Event Type
    Malfunction
    Date Received
    October 15, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 27, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THIS PRODUCT REMAINS IN-SERVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) RECEIVED INAPPROPRIATE THERAPY. THE PATIENT HAD A MONITOR ONLY ZONE SET UP AND THE PATIENT'S ARRHYTHMIA ORIGINATED IN THE MONITOR ONLY ZONE AND THEN ACCELERATED INTO THE VENTRICULAR TACHYCARDIA (VT) ZONE, WHICH RESULTED IN SHOCK THERAPY. THE PHYSICIAN BELIEVED THE PATIENT'S ARRHYTHMIA WAS SUPRAVENTRICULAR TACHYCARDIA (SVT). TECHNICAL SERVICES DISCUSSED DEVICE BEHAVIOR AND POSSIBLE PROGRAMMING OPTIONS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E110

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR E110| 4087| 0185