BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2735794 · Received September 7, 2012

    Report

    Report Number
    3007566237-2012-02168
    Event Type
    Injury
    Date Received
    September 7, 2012
    Date of Event
    April 4, 2012
    Report Date
    August 9, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    H050003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    LITERATURE: BEWERNICK, B. H., KAYSER, S., STURM, V., SCHLAEPFER, T. E. LONG-TERM EFFECTS OF NUCLEUS ACCUMBENS DEEP BRAIN STIMULATION IN TREATMENT-RESISTANT DEPRESSION: EVIDENCE FOR SUSTAINED EFFICACY. NEUROPSYCHOPHARMACOLOGY : OFFICIAL PUBLICATION OF THE AMERICAN COLLEGE OF NEUROPSYCHOPHARMACOLOGY. 2012;37(9):1975-1985. DOI: 10.1038/NPP.2012.44. SUMMARY: DEEP BRAIN STIMULATION (DBS) TO THE NUCLEUS ACCUMBENS (NACC-DBS) WAS ASSOCIATED WITH ANTIDEPRESSANT, ANXIOLYTIC, AND PRECOGNITIVE EFFECTS IN A SMALL SAMPLE OF PATIENTS SUFFERING FROM TREATMENT-RESISTANT DEPRESSION (TRD), FOLLOWED OVER 1 YEAR. RESULTS OF LONG-TERM FOLLOW-UP OF UP TO 4 YEARS OF NACC-DBS ARE DESCRIBED IN A GROUP OF 11 PATIENTS. CLINICAL EFFECTS, QUALITY OF LIFE (QOL), COGNITION, AND SAFETY ARE REPORTED. ELEVEN PATIENTS WERE STIMULATED WITH DBS BILATERAL TO THE NACC. MAIN OUTCOME MEASURES WERE CLINICAL EFFECT (HAMILTON DEPRESSION RATING SCALE, MONTGOMERY-ASPERG RATING SCALE OF DEPRESSION, AND HAMILTON ANXIETY SCALE) QOL (SF-36), COGNITION AND SAFETY AT BASELINE, 12 MONTHS (N¼11), 24 MONTHS (N¼10), AND LAST FOLLOW-UP (MAXIMUM 4 YEARS, N¼5). ANALYSES WERE PERFORMED IN AN INTENT-TO-TREAT METHOD WITH LAST OBSERVATION CARRIED FORWARD, THUS 11 PATIENTS CONTRIBUTED TO EACH POINT IN TIME. IN ALL, 5 OF 11 PATIENTS (45%) WERE CLASSIFIED AS RESPONDERS AFTER 12 MONTHS AND REMAINED SUSTAINED RESPONDERS WITHOUT WORSENING OF SYMPTOMS UNTIL LAST FOLLOW-UP AFTER 4 YEARS. BOTH RATINGS OF DEPRESSION AND ANXIETY WERE SIGNIFICANTLY REDUCED IN THE SAMPLE AS A WHOLE FROM FIRST MONTH OF NACC-DBS ON. ALL PATIENTS IMPROVED IN QOL MEASURES. ONE NON-RESPONDER COMMITTED SUICIDE. NO SEVERE ADVERSE EVENTS RELATED TO PARAMETER CHANGE WERE REPORTED. FIRST-TIME, PRELIMINARY LONG-TERM DATA ON NACC-DBS HAVE DEMONSTRATED A STABLE ANTIDEPRESSANT AND ANXIOLYTIC EFFECT AND AN AMELIORATION OF QOL IN THIS SMALL SAMPLE OF PATIENTS SUFFERING FROM TRD. NONE OF THE RESPONDERS OF FIRST YEAR RELAPSED DURING THE OBSERVATIONAL PERIOD (UP TO 4 YEARS). REPORTED EVENT: 1 PATIENT HAD A SEIZURE RELATED TO THE SURGICAL PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention