BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ICD LEAD

    MDR report key: 1151946 · Received September 5, 2008

    Report

    Report Number
    MW5008216
    Event Type
    Injury
    Date Received
    September 5, 2008
    Report Date
    September 5, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LEAD FRACTURE. INAPPROPRIATE SHOCKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ICD LEAD LWS MEDTRONIC 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| S