BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MDT FEDALIS ICD LEAD

    MDR report key: 1081424 · Received July 25, 2008

    Report

    Report Number
    MW5007797
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT HAS MALFUNCTIONING (FRACTURED) VLEAD (ICD LEAD) AND WAS RECEIVING INAPPROPRIATE SHOCKS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other