BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TELIGEN

    MDR report key: 3053289 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-05312
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 14, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS 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 THIS DEVICE SYSTEM DETECTED AN ARRHYTHMIA, WHERE THE PATIENT RECEIVED ANTI-TACHY PACING AND SIX SHOCKS FOR ATRIAL FIBRILLATION (AF) WITH A RAPID VENTRICULAR RATE (RVR). BOSTON SCIENTIFIC TECHNICAL SERVICES CONFIRMED THAT THERAPY WAS EXHAUSTED. A LOCAL AREA SALES REPRESENTATIVE REPORTED THAT THE DEVICE WAS REPROGRAMMED AND THE PATIENT RECEIVED AN INCREASE IN MEDICATION. TO DATE, NO ADVERSE PATIENT EFFECTS WERE REPORTED AS A RESULT OF THIS CLINICAL OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155539 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND E102

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR 0184| E102