BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC INC

    MDR report key: 545086 · Received July 15, 2004

    Report

    Report Number
    MW1032727
    Event Type
    Injury
    Date Received
    July 15, 2004
    Date of Event
    July 6, 2004
    Report Date
    July 13, 2004
    Manufacturer
    MEDTRONICS, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTS WITH INAPPROPRIATE CARDIAC DEFIBRILLATIONS SECONDARY TO LEAD FRACTURE WITH EXCESSIVE LEAD NOISE TRIGGERING THEIR AUTOMATIC IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (AICD).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC INC AICD LWS MEDTRONICS, INC. 7276 *
    2 * VENTRICULAR LEAD LWS MEDTRONICS, INC. 6945-65 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R VENTRICULAR LEAD.| AUTOMATIC IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR| (AICD).