BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 2494364 · Received March 16, 2012

    Report

    Report Number
    3007566237-2012-00560
    Event Type
    Death
    Date Received
    March 16, 2012
    Report Date
    February 16, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF DEATH WAS NOT PROVIDED. THIS REPORT IS REGARDING AN EVENT PUBLISHED IN A (B)(6) LANGUAGE ARTICLE AS REPORTED BY A MANUFACTURER REPRESENTATIVE. AT THE TIME OF THIS REPORT, AN ENGLISH VERSION OF THE ARTICLE COULD NOT BE OBTAINED. ATTEMPTS TO OBTAIN AN ENGLISH VERSION ARE IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN A STUDY INVOLVING THE USE OF DEEP BRAIN STIMULATION FOR DEPRESSION, THE PATIENT HAD BEEN NON-COMPLIANT WITH THE VISITS INVOLVED WITH THE STUDY AS WELL AS PSYCHIATRIC DRUGS-HE SUDDENLY STOPPED TAKING ALL PSYCHIATRIC MEDICATION. DURING MONTHLY TELEPHONE CALLS, THE HEALTHCARE PROFESSIONAL ATTEMPTED TO MOTIVATE THE PATIENT TO ATTEND STUDY VISITS AND BE CHECKED FOR SUICIDALITY. THE PATIENT SPENT SEVERAL WEEKS IN A PSYCHIATRIC HOSPITAL AND WAS FOLLOWED BY A PSYCHIATRIST WHO WAS REGULARLY INFORMED ABOUT THE STUDY PROCEEDINGS. THE PATIENT AGREED TO ATTEND A STUDY VISIT BUT HE COMMITTED SUICIDE PRIOR TO THE PLANNED DATE. THE PATIENT HAD UNDERGONE PARAMETER CHANGE(S) AND STIMULATOR REPLACEMENT SIX MONTHS PRIOR TO HIS DEATH. THE HEALTHCARE PROFESSIONAL DID NOT SUSPECT DEVICE INVOLVEMENT. THIS REPORT IS REGARDING AN EVENT PUBLISHED IN A (B)(6) LANGUAGE ARTICLE AS REPORTED BY A MANUFACTURER REPRESENTATIVE. AT THE TIME OF THIS REPORT, AN ENGLISH VERSION OF THE ARTICLE COULD NOT BE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LEAD MODEL UNKNOWN LOT# UNKNOWN