BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2353096 · Received November 30, 2011

    Report

    Report Number
    3004209178-2011-09497
    Event Type
    Malfunction
    Date Received
    November 30, 2011
    Report Date
    November 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3389S LOT# V063959 IMPLANTED: (B)(6) 2007 EXPLANTED: NA; LEAD MODEL 3389S LOT# V050963 IMPLANTED: (B)(6) 2007 EXPLANTED: NA; EXTENSION MODEL 7482A51 LOT# NHU164485V IMPLANTED: (B)(6) 2008 EXPLANTED: NA; EXTENSION MODEL 7482A51 LOT# NHU164486V IMPLANTED: (B)(6) 2008 EXPLANTED:NA; PROGRAMMER MODEL 7436 LOT# NFU013729P.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST THE IMPLANTABLE NEUROSTIMULATOR'S STIMULATION. THE DEVICE WAS NOTED TO BE POWERED OFF. THE PATIENT ALSO EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE NEUROSTIMULATOR WAS TURNED ON AND THE PATIENT BEGAN TO NOTE THE THERAPEUTIC EFFECTS OF THE STIMULATION. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1