BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INCEPTA

    MDR report key: 3213641 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09709
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    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 THE VENTRICULAR TACHYCARDIA MODE OF THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DEVICE WAS TURNED OFF AND PROGRAMMED TO MONITOR ONLY TRIGGERED RED ALERT. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THIS CRT D REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312625 INCEPTA IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND N164

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4271| 0125| 1810| 4513| 4269| 1861| 1823| H219| N164