BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDT-FIDELIS (6949)

    MDR report key: 1232243 · Received November 14, 2008

    Report

    Report Number
    MW5008992
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FRACTURE RV LEAD (DEFIB LEAD). REMOVED WITH LASER. LEAD REMOVED AND REPLACED WITH NEW RV DEFIB LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MDT-FIDELIS (6949) DEFIB RV LEAD LWS MEDTRONIC 6949

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR