BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1914902 · Received December 1, 2010

    Report

    Report Number
    3007566237-2010-10086
    Event Type
    Death
    Date Received
    December 1, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 22, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE PT INFORMATION PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PTS. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: BRONTE-STEWART H, LOUIE S, BATYA S, HENDERSON JM. CLINICAL MOTOR OUTCOME OF BILATERAL SUBTHALAMIC NUCLEUS DEEP-BRAIN STIMULATION FOR PARKINSON'S DISEASE USING IMAGE-GUIDED FRAMELESS STEREOTAXY. NEUROSURGERY. OCT 2101;67(4):1088-1093; DISCUSSION 1093. SUMMARY: THE AUTHORS REPORTED ON A GROUP OF 20 MEN AND 11 WOMEN WITH PARKINSON'S DISEASE (MEAN AGE OF 62 YEARS). TWENTY-EIGHT SUBJECTS HAD BILATERAL SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) AND 3 HAD UNILATERAL STN DBS USING A FRAMELESS APPROACH. THE AUTHORS INDICATED THAT THEIR OUTCOMES RESULTS ARE COMPARABLE TO THOSE REPORTED WITH THE USE OF THE FRAME-BASED TECHNIQUE. ALL PTS HAD POSTOPERATIVE CT SCANS WITHIN 6 HOURS OF THE PROCEDURE; MILD PNEUMOCEPHALUS WAS COMMON, BUT THERE WERE NO INTRACRANIAL HEMORRHAGES. REPORTABLE EVENT: ONE PT WITH PREMORBID SEVERE HYPERTENSION HAD A NORMAL POSTOPERATIVE CT SCAN AND NORMAL NEUROLOGICAL EXAMINATION 5 HOURS POST-DBS LEAD IMPLANTATION, BUT BECAME UNRESPONSIVE DURING THE FIRST POSTOPERATIVE NIGHT. REPEAT CT SCAN REVEALED A RIGHT FRONTAL PARENCHYMAL HEMORRHAGE AT THE ENTRY SITE OF THE LEAD WITH EXTENSION ALONG THE TRACK, BUT NO INTRAVENTRICULAR EXTENSION. THE PT WAS INITIALLY INTUBATED AND SUPPORTED BUT THE FAMILY REQUESTED REMOVAL OF ALL LIFE SUPPORT BASED ON THE PT'S PREOPERATIVE WISHES. HE DIED 6 DAYS LATER AND THE FAMILY REFUSED AN AUTOPSY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death EXTENSION: MODEL EXTENSION MVD, LOT# UNK| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL LEADMVD, LOT# UNK