BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 3073202 · Received April 23, 2013

    Report

    Report Number
    3007566237-2013-01404
    Event Type
    Injury
    Date Received
    April 23, 2013
    Report Date
    April 5, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE CAUSE OF THE SEIZURES WAS UNKNOWN BUT THE DEVICE WAS RULED OUT AS A CAUSE. THE PATIENT¿S DOCTOR DID A DEVICE SYSTEM CHECK TWO WEEKS AGO AND THE SYSTEM WAS WORKING AS EXPECTED HOWEVER SYMPTOMS WERE NOT CONTROLLED. HIS DEVICE WAS IMPLANTED FOR PAIN FROM SPASMS AND LEFT SIDED WEAKNESS CAUSED BY A STROKE IN 2000. HIS DOCTOR WAS AWARE THAT HE WAS HAVING SEIZURES. THEN IT WAS CLARIFIED THAT THE DEVICE DID NOT SEEM TO BE OPERATING PROPERLY, CAUSING HIM A LOT OF TIGHTNESS. AT HIS DOCTOR APPOINTMENT ABOUT A MONTH A AGO THE DEVICE WAS NOT ADJUSTED AND HE WAS TAKEN OFF SOME OF HIS MEDICATIONS TO SEE IF THAT WOULD HELP.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING SEIZURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175646 NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Other