BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2032517 · Received March 24, 2011

    Report

    Report Number
    3007566237-2011-02266
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    December 16, 2009
    Report Date
    February 28, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: PARK YS, KIM HY, CHANG WS, LEE PH, SOHN YH, CHANG JW. A COMPARISON OF LEDD AND MOTOR SCORES FOLLOWING STN-DBS TREATMENT IN PATIENT WITH YOUNG ONSET VS LATE ONSET PARKINSON'S DISEASE. NEUROMODULATION: TECHNOLOGY AT THE NEURAL INTERFACE. 2010;13(4):255-260. SUMMARY: THE AUTHORS COMPARED THE ROLE OF SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS) IN THE MANAGEMENT OF MEDICALLY REFRACTORY IDIOPATHIC PARKINSON'S DISEASE IN PATIENTS WITH RELATIVELY YOUNG ONSET (B)(6) PARKINSON'S DISEASE (YOPD) AND PATIENTS WITH RELATIVELY LATE ONSET PARKINSON'S DISEASE ((B)(6), RLOPD). BETWEEN (B)(6) 2000 AND (B)(6) 2008, THE AUTHORS TREATED 132 PATIENTS, OF THESE PATIENTS, 33 (25%) MET DISEASE ONSET CRITERIA, AND WERE INCLUDED IN THE STUDY SAMPLE: 18 (10 MEN, EIGHT WOMEN) YOPD PATIENTS, AND 15 (SIX MEN, NINE WOMEN) RLOPD. PEROPERATIVE DYSKINESIA WAS MORE COMMON IN YOPD PATIENTS AND, PSYCHOTIC PROBLEMS WERE MORE COMMON IN RLOPD PATIENTS. OUR RESULTS SUGGEST THE AGE OF ONSET DOES NOT INFLUENCE RESPONSE TO STN-DBS PARKINSON'S DISEASE PATIENTS. THERE WERE NO DIFFERENCES IN POSTOPERATIVE WEIGHT GAIN BETWEEN THE TWO GROUPS. THERE WAS NO MORTALITY RELATED TO STN-DBS IN OUR STUDY. NO PATIENT REQUIRED IMMEDIATE STIMULATOR REPOSITIONING IMMEDIATELY FOLLOWING STN-DBS. REPORTABLE EVENT: IT WAS REPORTED THAT ONE RLOPD PATIENT HAD AN EPIDURAL HEMATOMA AND CRANIOTOMY DUE TO A MOTOR VEHICLE INJURY THREE YEARS FOLLOWING THE PROCEDURE. THE AUTHORS DID NOT REMOVE THE RIGHT PROXIMAL ELECTRODE, BUT THE STIMULATION WAS TURNED OFF AS THE ELECTRODE HAD MIGRATED. SEE LITERATURE ARTICLE WITH MFR REPORT# 3007566237-2011-02256. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. THE PATIENT INFORMATION PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PATIENTS WITHIN THE RLOPD GROUP. AT THIS TIME, NO ADDITIONAL INFORMATION WAS AVAILABLE, ADDITIONAL INFORMATION REGARDING THE PATIENT, EVENT AND OUTCOME HAS BEEN REQUESTED.

    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 58 YR Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# UNKNOWN| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| EXPLANTED:| IMPLANTED: