BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6096209 · Received November 11, 2016

    Report

    Report Number
    3007566237-2016-04054
    Event Type
    Death
    Date Received
    November 11, 2016
    Date of Event
    August 21, 2016
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    RYU, H.S., KIM, M.S., YOU, S., KIM, M-J., KIM, Y.J., KIM, J., KIM, K., CHUNG, S.J. MORTALITY OF ADVANCED PARKINSON'S DISEASE PATIENTS TREATED WITH DEEP BRAIN STIMULATION SURGERY. JOURNAL OF THE NEUROLOGICAL SCIENCES. 2016;369:230-235. SUMMARY: DESPITE THE WIDESPREAD USE OF DEEP BRAIN STIMULATION (DBS) FOR PATIENTS WITH PARKINSON'S DISEASE (PD), LONG-TERM OUTCOMES REMAIN UNCLEAR. WE AIMED TO ANALYZE THE MORTALITY OF ADVANCED PD PATIENTS WHO RECEIVED DBS SURGERY. REPORTED EVENTS: 2 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) FOR PARKINSONS DISEASE (PD) DIED DUE TO INTENTIONAL SELF-HARM/SUICIDE. ONE PATIENT WITH DBS FOR PD DIED DUE TO DROWNING AND SUBMERSION WHILE IN THE BATHTUB. THREE PATIENTS WITH DBS FOR PD DIED DUE TO DEMENTIA. THERE WAS NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746104 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death