BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2100652 · Received May 17, 2011

    Report

    Report Number
    3007566237-2011-03599
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    January 1, 2009
    Report Date
    June 30, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THIS REPORT IS BEING SUBMITTED LATE DUE TO A DELAY BY AN MFR EMPLOYEE. A PROCESS IMPROVEMENT PLAN AND TRAINING ARE IN PLACE.

    Description of Event or Problem · 1

    LITERATURE: HSU H-F, CHENG H-Y, YANG S-H, LIANG C-C. REHABILITATION ASSISTS IN RECOVERY AFTER COMPLICATED INTRACEREBRAL HEMORRHAGE RELATED TO DEEP BRAIN STIMULATION. TZU CHI MEDICAL JOURNAL. 2010;22(1):61-64. SUMMARY: THIS ARTICLE DISCUSSED A PT WHO UNDERWENT AN INPATIENT REHABILITATION PROGRAM BECAUSE OF COMPLICATED INTRACEREBRAL HEMORRHAGE AFTER A DBS PROCEDURE. IT ALSO REVIEWS THE CURRENT LITERATURE REPORTING COMPLICATIONS FOLLOWING DBS. EVENT: A (B)(6) MAN WHO WAS DIAGNOSED WITH PARKINSON'S DISEASE 12 YRS AGO SUFFERED RIGHT HEMIPARESIS 7 HRS AFTER THE DBS INSERTION OPERATION. MANUAL MUSCLE TESTS OF THE RIGHT UPPER AND LOWER LIMBS WERE GRADED 2. EMERGENCY BRAIN COMPUTED TOMOGRAPHY SHOWED HEMORRHAGE AT THE TIP OF THE LEFT ELECTRODE IN THE LEFT CEREBRAL PEDUNCLE. THE PT WAS GIVEN MEDICATION TO REDUCE INTRACRANIAL PRESSURE AND WAS PUT INTO AN INPATIENT REHABILITATION PROGRAM ONE WEEK LATER. THE PT RECEIVED PHYSICAL AND OCCUPATIONAL THERAPY ON A DAILY BASIS. AFTER APPROXIMATELY 1 AND ONE HALF MONTHS, THE PT HAD ALMOST REACHED HIS REHABILITATION GOALS. DBS REMAINED TURNED OFF DURING THIS TIME. AROUND ONE MONTH LATER, THE PT RETURNED TO NEUROSURGERY FOR A BATTERY IMPLANTATION AND PROGRAMMING. IT IS UNCLEAR WHETHER THE PT HAD ONE OR TWO DEVICE SETS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O EXPLANTED:| LEAD: MODEL LEADMVD, LOT# UNK| IMPLANTED: