BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC (MEDTRONIC)

    MDR report key: 1081416 · Received July 16, 2008

    Report

    Report Number
    MW5007789
    Event Type
    Injury
    Date Received
    July 16, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A 2/5 DI ICD PLACED. TWO OPERATIONS. FIRST TIME REPLACEMENT - SECOND TIME WIRES OF ICD OFF SET. PROBLEM WITH ICD DURING THE TIME OF HAVING IT IMPLANTED. SHOCK SEVERAL TIMES. SWELLING AND BLOATED. DIAGNOSIS OR REASON FOR USE: HEART WEAKEN. CONTROL BLOOD FLOW. DATES OF USE: 2008

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC (MEDTRONIC) DEFIBRILLATOR LWS MEDTRONIC 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 * Life Threatening