BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2845052 · Received November 26, 2012

    Report

    Report Number
    3007566237-2012-02829
    Event Type
    Malfunction
    Date Received
    November 26, 2012
    Report Date
    October 29, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A DEVICE IMPLANTED ON HIS RIGHT SIDE (B)(6) 2010 THAT STOPPED WORKING A WEEK AGO. NO FALLS WERE KNOWN TO BE RELATED TO THIS EVENT. THE PATIENT STATED THAT A MEDICAL ASSISTANT TOLD HIM "NOT TO BOTHER WITH THE PROGRAMMER". THE PATIENT STATED THAT HE WAS SHAKING TERRIBLY, AND HE HAD NOT RECEIVED ANSWERS FROM HIS DOCTOR. THE PATIENT STATED THAT WHEN HE WAS REPROGRAMMED, THERAPY ONLY LASTED FOR A WEEK. ONE REPROGRAMMING SESSION WAS "BETTER", BUT HAD STOPPED WORKING AGAIN. THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND RECEIVED A POR NOTIFICATION. THE POR WAS NOT ABLE TO BE CLEARED. THREE WEEKS LATER, THE PATIENT WAS REPROGRAMMED AND THERAPY WAS REPORTED TO BE "WORKING FINE". NO FURTHER INFORMATION WAS REPORTED. REFER TO MANUFACTURING REPORT# 3007566237-2012-02828. A MALFUNCTION WAS ALLEGED ON TWO SYSTEMS THAT WERE IN CONCURRENT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1