BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 1951394 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-22799
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 24, 2010
    Report Date
    December 9, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CRT-D REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE CRT-D HAD BEEN PROGRAMMED TO MONITOR ONLY DUE TO AN UNRELATED SURGICAL PROCEDURE IN A DIFFERENT HOSPITAL. ONCE THE PROCEDURE WAS COMPLETED, THE PHYSICIANS FORGOT TO REPROGRAM THE DEVICE BACK TO MONITOR AND THERAPY MODE. AFTER THE ALERT WAS ISSUED, THE PATIENT WAS CALLED INTO THE CLINIC AND THE DEVICE WAS APPROPRIATELY PROGRAMMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE CRT-D REMAINS IMPLANTED AND IN SERVICE. 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 A RED ALERT WAS ISSUED THROUGH THE LATITUDE SYSTEM AFTER IT WAS DETECTED THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS PROGRAMMED TO MONITOR ONLY. THE PHYSICIAN WAS NOTIFIED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND F103

    Patients

    Seq Age Sex Outcome Treatment
    1 Other