BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1652748 · Received April 6, 2010

    Report

    Report Number
    3007566237-2010-02766
    Event Type
    Injury
    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 Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) - USED FOR SUICIDAL IDEATION.

    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 PTS SUFFERING FROM VERY RESISTANT FORMS OF DEPRESSION. REPORTABLE EVENT: ONE PT ATTEMPTED SUICIDE WHICH WAS UNRELATED TO DBS. THE ARTICLE NOTED THE SUICIDE ATTEMPT WAS RELATED TO NON-COMPLIANCE OF THE PT (UNPREDICTABLE, SUDDEN OMISSION OF ALL MEDICATIONS AND REFUSAL TO ATTEND STUDY VISITS TO ADJUST STIMULATION PATTERNS). THE EVENT WAS NOT RELATED TO PARAMETER CHANGES. THE PT HAD ATTEMPTED SUICIDE PRIOR TO ENTERING THE STUDY. THE PT IS NOW CLASSIFIED AS A RESPONDER WITH STABLE STIMULATION PARAMETERS. SEE LITERATURE ARTICLE WITH MFR REPORT #3007566237-2010-02753.

    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 Life Threatening EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| IMPLANTED:| EXPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNKNOWN| IMPLANTED:| LEAD: MODEL 3387, LOT# UNKNOWN| IMPLANTED:| EXPLANTED: