BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 4861847 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-12023
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 15, 2015
    Report Date
    June 1, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PARKINSON¿S DISEASE PATIENT EXPERIENCED ¿STIFF LIMBS¿ SINCE 2015 (B)(6). THERE HAD BEEN NO TROUBLESHOOTING PERFORMED AND THE CAUSE OF THE ISSUE WAS NOT DETERMINED. THE PATIENT CONTINUED TO EXPERIENCE STIFF LIMBS AT THE TIME OF REPORT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406203 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR