BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC FIDELIS DEFIB LEAD

    MDR report key: 1081425 · Received July 25, 2008

    Report

    Report Number
    MW5007798
    Event Type
    Malfunction
    Date Received
    July 25, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 17, 2008
    Manufacturer
    MEDTRONIC
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    MALFUNCTIONED DEFIB LEAD. (FIDELIS MEDTRONIC) GIVING INAPPROPRIATE SHOCKS TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC FIDELIS DEFIB LEAD DEFIB LEAD RV LEAD LWS MEDTRONIC 6949 LFJ074742

    Patients

    Seq Age Sex Outcome Treatment
    1 Other