BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1123864 · Received August 15, 2008

    Report

    Report Number
    9614453-2008-04958
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 2008
    Manufacturer
    MEDTRONIC SWISS MANUFACTURING FACILITY
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE DEVICE REACHED END OF SERVICE (EOS) 8 MONTHS AFTER IMPLANT. NO PT INJURY WAS REPORTED. THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC SWISS MANUFACTURING FACILITY 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention