BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINETRA

    MDR report key: 1652812 · Received April 6, 2010

    Report

    Report Number
    3007566237-2010-02768
    Event Type
    Death
    Date Received
    April 6, 2010
    Date of Event
    February 28, 2010
    Report Date
    March 8, 2010
    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) - USED FOR SUICIDAL IDEATION - (B) (4).

    Description of Event or Problem · 1

    LITERATURE: BEWERNICK BH, HURLEMANN R, MATUSCH A, ET AL. NUCLEUS ACCUMBENS DEEP BRAIN STIMULATION DECREASES RATINGS OF DEPRESSION AND ANXIETY IN TREATMENT-RESISTANT DEPRESSION. BIOL PSYCHIATRY. 2010;67(2):110-116. SUMMARY: THE ARTICLE DESCRIBES THE LONG-TERM EFFECTS OF DBS IN THE NUCLEUS ACCUMBENS IN TEN PATIENTS SUFFERING FROM VERY RESISTANT FORMS OF DEPRESSION. REPORTABLE EVENT: ONE PATIENT COMMITTED SUICIDE DURING THE FOLLOW-UP PERIOD. THE SUICIDE TOOK PLACE DURING A PERSONAL CRISIS CAUSED BY CRITICAL LIFE EVENTS (SEPARATION FROM PARTNER, CONFLICTS WITH CLOSE RELATIVES) WHICH WERE NOT COUNTERACTED BY THEIR PSYCHIATRIST. AT THE TIME, THE PATIENT WAS UNABLE TO ATTEND STUDY VISITS FOR A STIMULATION PARAMETER CHANGE. THE PATIENT HAD ATTEMPTED SUICIDE PRIOR TO ENTERING THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| L IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| EXPLANTED: