BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATION LEAD

    MDR report key: 1057804 · Received June 6, 2008

    Report

    Report Number
    2182207-2008-03034
    Event Type
    Injury
    Date Received
    June 6, 2008
    Report Date
    May 8, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: BLOMSTEDT P, HARIZ MI, LEES A, ET AL. ACUTE SEVERE DEPRESSION INDUCED BY INTRAOPERATIVE STIMULATION OF THE SUBSTANTIA NIGRA: A CASE REPORT. PARKINSONISM RELAT DISORD 2008; 14(3): 253-256. WE PRESENT A MAN WITH PARKINSON'S DISEASE (PD) WHO UNDERWENT BILATERAL STIMULATION IN THE SUBTHALAMIC NUCLEUS (STN). DURING THE INTRAOPERATIVE EVALUATION, STIMULATION THROUGH THE LOWEST CONTACT IN THE RIGHT STN AREA, INDUCED AN ACUTE DEPRESSIVE STATE, DURING WHICH THE PT WAS CRYING AND EXPRESSING THAT HE DID NOT WANT TO LIVE. THE PT RETURNED TO HIS NORMAL STATE OF MOOD WITHIN SECONDS AFTER THE CESSATION OF STIMULATION. REPEATED BLINDED STIMULATIONS RESULTED IN THE SAME RESPONSE IMMEDIATE POSTOPERATIVE MAGNETIC RESONANCE IMAGING (MRI) REVEALED THAT THE LOWEST CONTACT OF THE RIGHT ELECTRODE WAS LOCATED IN THE SUBSTANTIA NIGRA. REPORTABLE EVENT: THE PT HAS NOW BEEN FOLLOWED FOR 5 YEARS. DURING THIS PERIOD, NO CHANGES IN MOOD HAVE BEEN NOTED, NOR ANY OTHER PSYCHOLOGICAL OR COGNITIVE CHANGE. THE MAIN RECENT COMPLAINTS HAVE BEEN GAIT AND BALANCE DIFFICULTIES, FREEZING OF GAIT AND STUTTERING (FREEZING OF SPEECH) WHEN ON MEDICATION AND ON STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATION LEAD MHY MEDTRONIC NEUROMODULATION 3389 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other IPG MODEL UNK N=1| PROGRAMMER MODEL UNK N=1| EXTENSION MODEL UNK N=2| LEAD MODEL 3389 N=1