BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 7644006 · Received June 27, 2018

    Report

    Report Number
    3007566237-2018-01917
    Event Type
    Death
    Date Received
    June 27, 2018
    Date of Event
    April 19, 2018
    Report Date
    June 27, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MFR
    PMA / PMN Number
    H050003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THE ACTUAL DATE OF DEATH WAS NOT PROVIDED IN THE LITERATURE ARTICLE; THIS DATE IS BASED ON THE DATE OF ARTICLE PUBLICATION. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. FITZGERALD, PB, SEGRAVE, R, RICHARDSON, KE, KNOX, LA., HERRING, S., DASKALAKIS, ZJ., BITTAR, RG. A PILOT STUDY OF BED NUCLEUS OF THE STRIA TERMINALIS DEEP BRAIN STIMULATION IN TREATMENT-RESISTANT DEPRESSION. BRAIN STIMUL. 2018. DOI: 10.1016/J.BRS.2018.04.013. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: STUDIES ARE INCREASINGLY INVESTIGATING THE THERAPEUTIC EFFECTS OF DEEP BRAIN STIMULATION (DBS) APPLIED TO A VARIETY OF BRAIN REGIONS IN THE TREATMENT OF PATIENTS WITH HIGHLY TREATMENT REFRACTORY DEPRESSION. LIMITED RESEARCH TO DATE HAS INVESTIGATED THE THERAPEUTIC POTENTIAL OF DBS APPLIED TO THE BED NUCLEUS OF STRIA TERMINALIS (BNST). OBJECTIVE: THE AIM OF THIS STUDY WAS TO EXPLORE THE THERAPEUTIC POTENTIAL OF DBS APPLIED TO THE BNST. METHOD: FIVE PATIENTS WITH HIGHLY TREATMENT RESISTANT DEPRESSION UNDERWENT DBS TO THE BNST IN AN OPEN LABEL CASE SERIES DESIGN. RESULTS: BNST DBS RESULTED IN SUSTAINED REMISSION OF DEPRESSION IN TWO OF THE FIVE PATIENTS, PROVIDED SUBSTANTIAL THERAPEUTIC IMPROVEMENT TWO FURTHER PATIENTS, AND HAD MINIMAL ANTIDEPRESSANT EFFECT FOR THE FINAL PATIENT. THERE WERE NO OPERATIVE COMPLICATIONS AND STIMULATION RELATED SIDE EFFECTS WERE LIMITED AND REVERSIBLE WITH ADJUSTMENT OF STIMULATION. HOWEVER, THE TIME TO ACHIEVE AND COMPLEXITY OF PROGRAMMING REQUIRED TO ACHIEVE OPTIMAL THERAPEUTIC OUTCOMES VARIED SUBSTANTIALLY BETWEEN PATIENTS. CONCLUSION: DBS APPLIED TO THE BNST AS THERAPEUTIC POTENTIAL IN PATIENTS WITH HIGHLY REFRACTORY DEPRESSION AND WARRANTS EXPLORATION IN LARGER CLINICAL STUDIES. REPORTED EVENTS: 1. A FEMALE PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) OF THE BED NUCLEUS OF THE STRIA TERMINALIS (BNST) FOR DEPRESSION WAS A NON-RESPONDER TO STIMULATION THERAPY TOOK AN OVERDOSE WITH SOME DEGREE OF SUICIDAL INTENT. THE ATTEMPT DID NOT OCCUR WITHIN 2 WEEKS OF A STIMULATION ADJUSTMENT AND DID NOT APPEAR TO BE RELATED TO STIMULATION INDUCED EFFECTS. THE PATIENT EXPERIENCED NO PERSISTENT ADVERSE CONSEQUENCES AS A RESULT. HOWEVER, THEIR ELECTRODES WERE EVENTUALLY EXPLANTED AND NEW ELECTRODES IMPLANTED TARGETING THE SUBGENUAL ANTERIOR CINGULATE. THEY SUBSEQUENTLY COMMITTED SUICIDE WHILE UNDERGOING OPEN LABEL TREATMENT AT THE SECOND DBS STIMULATION TARGET. PATIENTS WERE IMPLANTED WITH 3387 MODEL LEADS AND 37612 ACTIVA RC NEUROSTIMULATORS. IT WAS NOT POSSIBLE TO ASCERTAIN ANY OTHER SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482961 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MFR MEDTRONIC NEUROMODULATION 37612 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death