BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1083248 · Received July 26, 2008

    Report

    Report Number
    MW5007807
    Event Type
    Injury
    Date Received
    July 26, 2008
    Date of Event
    July 25, 2008
    Report Date
    July 26, 2008
    Manufacturer
    UNK
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KY, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAVE A MEDTRONIC IMPLANTABLE PACEMAKER/DEFIBRILLATOR THAT WAS INSTALLED IN 2005. IN 2008, MY DEFIBRILLATOR WENT OFF AND SHOCKED ME 5 TIMES WITHIN A 3 MINUTE PERIOD. UPON ARRIVING AT THE EMERGENCY ROOM AT MY HOSP, I WAS CHECKED OUT AND THEY DISCOVERED THAT MY LEAD TO THE DEFIBRILLATOR WAS FRACTURED. I NOW HAVE A SURGERY DATE OF THREE DAYS LATER, TO HAVE THE LEAD EITHER REMOVED AND REPLACED OR ANOTHER LEAD IMPLANTED TO REPLACE THE DEFECTIVE LEAD. I RECEIVED A LETTER FROM MY MONITORING COMPANY ABOUT THIS POSSIBLE DEFECT LAST WEEK. DATES OF USE: 2005 - 2008. DIAGNOSIS OR REASON FOR USE: LOW EJECTION FRACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PACEMAKER/DEFIBRILLATOR LWS UNK HEART LEAD

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L