BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2071743 · Received April 25, 2011

    Report

    Report Number
    3007566237-2011-03050
    Event Type
    Death
    Date Received
    April 25, 2011
    Date of Event
    December 24, 2010
    Report Date
    March 23, 2011
    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 INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION REGARDING THE PATIENT AND EVENT HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: SUTCLIFFE AJ, MITCHELL RD, GAN YC, MOCROFT AP, NIGHTINGALE P. GENERAL ANAESTHESIA FOR DEEP BRAIN STIMULATOR ELECTRODE INSERTION IN PARKINSON'S DISEASE. ACTA NEUROCHIR (WIEN). MAR 2011;153(3):621-627. SUMMARY: THE AUTHORS COMPARE THE USE OF GENERAL AND LOCAL ANESTHETIC IN PATIENTS HAVING DEEP BRAIN STIMULATOR (DBS) SURGERY. THIS WAS A RETROSPECTIVE CASE NOTE STUDY OF 46 PATIENTS TREATED CONSECUTIVELY WITH SUBTHALAMIC NUCLEUS STIMULATION FOR PARKINSON'S DISEASE AS PRACTICE CHANGED IN A NEUROSURGICAL UNIT. THE FIRST 20 PATIENTS (LA GROUP) HAD PERMANENT ELECTRODES PLACED IN THE SUBTHALAMIC NUCLEUS UNDER LOCAL ANESTHESIA BETWEEN (B)(6) 1999 AND (B)(6) 2002. THE REMAINING 26 PATIENTS (GA GROUP) HAD THE ENTIRE PROCEDURE UNDER GENERAL ANESTHESIA FROM (B)(6) 2002 ONWARDS. THE GROUPS WERE SIMILAR FOR AGE, SEX, DURATION OF PARKINSON'S DISEASE AND PREOPERATIVE LEVODOPA REQUIREMENT. THE AUTHORS REPORTED THAT IN THIS SAMPLE SET, THERE WAS NO DIFFERENCE IN THE ADVERSE EFFECTS SEEN IN PATIENTS UNDERGOING DEEP BRAIN STIMULATOR INSERTION WITH GENERAL ANESTHETIC COMPARED WITH LOCAL ANESTHETIC AND THE USE OF GENERAL ANESTHETIC DID NOT DETRACT FROM THE KNOWN BENEFITS OF SURGERY. REPORTABLE EVENT: ALL PATIENTS WERE ADMITTED ON THE DAY BEFORE SURGERY, DIFFERENCES IN THE LENGTH OF HOSPITAL STAY WERE A REFLECTION OF EVENTS IN THE PERI- AND POSTOPERATIVE PERIOD. IN THE LA GROUP, ONE PATIENT DIED AS A RESULT OF A HEMATOMA THAT DEVELOPED INTRAOPERATIVELY AT THE TRACK SITE OF A PERMANENT ELECTRODE. THE HEMATOMA WAS CAUSED BY THE FIRST ELECTRODE BUT DID NOT BECOME APPARENT UNTIL THE SECOND ELECTRODE HAD BEEN POSITIONED. THIS PATIENT REMAINED IN HOSPITAL FOR 13 DAYS AND WAS EXCLUDED FROM THE RESULTS DESCRIBING POSTOPERATIVE LEVODOPA REQUIREMENTS.

    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 Death| H| O EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| LEAD: MODEL LEADMVD, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: