BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIK

    MDR report key: 1103405 · Received August 7, 2008

    Report

    Report Number
    MW5007929
    Event Type
    Malfunction
    Date Received
    August 7, 2008
    Date of Event
    July 31, 2008
    Report Date
    August 7, 2008
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ICD FAILED AND AS A RESULT THE PATIENT HAD TO UNDERGO 2 OTHER PROCEDURES WHILE THE PRACTITIONERS TRIED TO DETERMINE IF THERE WAS A FAILURE WITH THE CARDIAC LEADS. ULTIMATELY, THE FAILURE WAS FOUND TO BE WITH THE DEVICE, AND IT WAS REPLACED WITH ANOTHER DEVICE. DIAGNOSIS OR REASON FOR USE: CHRONIC VENTRICULAR FIBRILLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIK VIRTUOSO ICD LWS PUL454638H

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other