BEUDAMED
    FDA Adverse Event Summary report: N

    AICD

    MDR report key: 1083417 · Received July 20, 2008

    Report

    Report Number
    1083417
    Date Received
    July 20, 2008
    Date of Event
    June 3, 2008
    Report Date
    July 20, 2008
    Manufacturer
    MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT
    Product Code
    LWS
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    THE AICD GENERATOR AND LEADS WERE PLACED. THE PATIENT QUICKLY DEVELOPED SIGNS OF WOUND INFECTION, AND TWO WEEKS LATER, THE DEVICE WAS EXPLANTED. WE ARE CURRENTLY AWAITING RESULTS FROM THE MANUFACTURER REGARDING THESE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AICD GENERATOR, AICD LWS MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT D154AWG NA
    2 RA LEAD, AICD LWS MEDTRONIC INC. CARDIAC RHYTHM DISEASE MANAGEMENT 5076-52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR