BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2455897 · Received February 16, 2012

    Report

    Report Number
    3004209178-2012-01014
    Event Type
    Malfunction
    Date Received
    February 16, 2012
    Report Date
    February 10, 2012
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXTENSION MODEL # 748251 LOT # NHU112010V IMPLANTED 2006-(B)(6) EXPLANTED UNKNOWN; EXTENSION MODEL # 748251 LOT # NHU112009V IMPLANTED 2006-(B)(6) EXPLANTED UNKNOWN; LEAD MODEL # 3389-40 LOT # V003007 IMPLANTED 2006-(B)(6) EXPLANTED UNKNOWN; LEAD MODEL # 3389-40 LOT # V002947 IMPLANTED 2006-(B)(6) EXPLANTED UNKNOWN; PROGRAMMER MODEL # 7436 LOT # NFU025918P.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING AN UNRELATED MEDICAL PROCEDURE. THE PATIENT WAS IN THE HOSPITAL FOR AN EXTENDED PERIOD OF TIME. THE PATIENT HAD NOT FELT GOOD FOR AWHILE. THE DEVICE WAS LAST CHECKED IN (B)(6) 2011. THE PATIENT FELT A SURGE AND PULLING OF THE MOUTH WHEN SHE USED THE THERAPY CONTROLLER ON BUTTON. IT WAS REVIEWED THAT THE THERAPY MAY HAVE BEEN OFF. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    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