BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEEP BRAIN STIMULATOR

    MDR report key: 1864448 · Received October 6, 2010

    Report

    Report Number
    3007566237-2010-07682
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 1, 2009
    Report Date
    September 15, 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). (SUICIDE ATTEMPT; NO MOTIVATION; NO INTEREST). IT WAS NOT POSSIBLE TO ASCERTAIN DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS.

    Description of Event or Problem · 1

    LITERATURE: NEUNER I, HALFTER S, WOLLENWEBER F, PODOLL K, SCHNEIDER F. NUCLEUS ACCUMBENS DEEP BRAIN STIMULATION DID NOT PREVENT SUICIDE ATTEMPT IN TOURETTE SYNDROME. BIOL PSYCHIATRY. AUG 15 2010; 68(4): E19-20. SUMMARY: THIS IS A CASE STUDY ON A PT WHO REC'D BILATERAL STIMULATION IN THE NUCLEUS ACCUMBENS BECAUSE OF A TREATMENT-REFRACTORY TOURETTE SYNDROME. HE WAS IMPLANTED BILATERALLY AT THE ANTERIOR LIMB OF THE INTERNAL CAPSULE. IT WAS INDICATED THAT THE TICS DECREASED BY 60% 3 MONTHS AFTER SURGERY AND 58% AFTER 36 MONTHS. OCD SYMPTOMS IMPROVED. EVENT: THE PT ATTEMPTED SUICIDE BY INTOXICATION WITH LORAZEPAM; DOXEPIN AND ZOPICLONE. PRECAUTIONS WERE TAKEN NOT TO BE FOUND; PT SURVIVED THE SUICIDE ATTEMPT ONLY BY CHANCE. THE DBS SYSTEM WAS CHECKED AND FOUND RUNNING WITHOUT SIGNS OF BATTERY FAILURE, ELECTRODE BREAKS, AND SO ON. AFTER 4 WEEKS OF INTENSIVE CARE AND NEUROLOGICAL REHABILITATION, HE WAS ADMITTED TO PSYCHIATRY. WITH THE EXCEPTION OF A CRITICAL ILLNESS POLYNEUROPATHY, HE DID NOT SUFFER PERMANENT NEUROLOGIC DEFICITS. ON ADMISSION TO PSYCHIATRY, PT EXPERIENCED MAJOR DEPRESSION, NO MOTIVATION, AND LACK OF INTEREST. THIS DECLINED OVER A PERIOD OF 3 MONTHS BEFORE THE SUICIDE ATTEMPT. THERE WERE JOB AND RELATIONSHIP ISSUES AND CONFLICT WITH A NEIGHBOR. THE PT INDICATED THAT SELF-AGGRESSIVE BEHAVIOR HAD RETURNED (BITING HIS LIP, SLAMMING HIS NECK WITH HIS RIGHT FIST) AND HE HIT THE WALLS. PT INDICATED THAT THE DBS WAS WORKING BECAUSE TIC FREQUENCY WAXED AND WANED BUT WERE NOT SEVERELY AGGRAVATED. SLOWLY OVER A PERIOD OF 9 WEEKS, THE MAJOR DEPRESSIVE EPISODE RESOLVED. THE DBS WAS CHECKED AND INCREASED FROM 4.2 TO 6.0V. IT HAD BEEN REDUCED TO 4.2 V DURING REHABILITATION, BUT THE PT FELT THAT THE TICS WORSENED UNDER THE REDUCED STIMULATION INTENSITY. FIFTY EIGHT MONTHS AFTER SURGERY THE TICS DECREASED BY 57%.

    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 42 YR Life Threatening UNKNOWN CONVERSION TYPE: MODEL LEADN, LOT# UNKNOWN| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNKNOWN