BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1231030 · Received October 30, 2008

    Report

    Report Number
    9614453-2008-07064
    Event Type
    Malfunction
    Date Received
    October 30, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 2, 2008
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE NEUROSTIMULATOR GOES TO A POWER ON RESET (POR) STATE FOR NO APPARENT REASON. THE DEVICE HAD TO BE REPROGRAMMED. THE PATIENT RESUMED THERAPY. THE DEVICE WILL BE REPLACED. THE SURGEON WILL ARRANGE THIS AS SOON S POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC EUROPE SARL 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention