BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 2162129 · Received July 8, 2011

    Report

    Report Number
    3007566237-2011-05262
    Event Type
    Death
    Date Received
    July 8, 2011
    Date of Event
    March 1, 2011
    Report Date
    June 7, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P860009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO REGARDING THE PT, EVENT, INTERVENTIONS AND OUTCOME HAS BEEN....

    Description of Event or Problem · 1

    LITERATURE: SOULAS T, SULTAN S, GURRUCHAGA JM, PALFI S, FENELON G. DEPRESSION AND COPING AS PREDICTORS OF CHANGE AFTER DEEP BRAIN STIMULATION IN PARKINSON'S DISEASE. WORLD NEUROSURG. MAR-APR 2011;75(3-4):525-532. DOI: 10.1016/J.WNEU.2010.06.015. SUMMARY: THE AIM OF THE PRESENT STUDY WAS TO EVALUATE THE POSITIVE IMPACT OF SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS) ON MOTOR SYMPTOMS AND TO QUANTIFY THE CHANGES IN QOL, ANXIETY, AND DEPRESSION AFTER SURGERY. THE STUDY WAS CONDUCTED FROM (B)(6) 2004 THROUGH (B)(6) 2007. A TOTAL OF 41 CONSECUTIVE PATIENTS PARTICIPATED IN THIS STUDY. REPORTABLE EVENT: DURING THE FIRST 6 MONTHS AFTER THE OPERATION, TWO PATIENTS HAD THEIR STIMULATION ELECTRODES REMOVED DUE TO AN INFECTION AND ONE PT COMMITTED SUICIDE.

    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| R EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LOT# UNK| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK| IMPLANTED:| IMPLANTABLE PULSE GENERATOR: MODEL IPGNEURO,| EXPLANTED:| UNK CONVERSION TYPE: MODEL LEADN, LOT# UNK