BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR LEAD

    MDR report key: 996477 · Received February 6, 2008

    Report

    Report Number
    2182207-2008-00618
    Event Type
    Injury
    Date Received
    February 6, 2008
    Report Date
    January 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: OKAJIMA, ET AL. "EXPERIENCE OF ANESTHESIA FOR PTS WITH DEEP BRAIN STIMULATORS." MASUI 2007; 56(10): 1211-1213. THIS ARTICLE DESCRIBES A CASE REPORT OF A MALE PT, WITH DBS WHO UNDERGOES ABDOMINAL SURGERY. UPON TURNING THE DEVICE BACK ON POST-SURGERY, PARKINSON SYMPTOMS RETURN OVER THE NEXT 6 HRS. DEVICE NO LONGER SEEMED EFFECTIVE. PT EXPERIENCED PARKINSON SYMPTOMS, AKINESIA, STIFFNESS, SEVERE HEAT AND PAIN, AFTER TURNING THE DEVICE BACK ON POST-SURGERY. DEVICE SEEMED TO BE NO LONGER EFFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATOR LEAD MHY MEDTRONIC NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other IMPLANTABLE EXTENSION MODEL UNK| IMPLANTABLE NEUROSTIMULATOR MODEL UNK