BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2950856 · Received February 8, 2013

    Report

    Report Number
    3007566237-2013-00431
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    September 1, 2012
    Report Date
    January 17, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    HAMANI, C., GIACOBBE, P., DIWAN, M., BALBINO, E., TONG, J., BRIDGMAN, A., LIPSMAN, N., LOZANO, A. M., KENNEDY, S. H., NOBREGA, J. N. MONOAMINE OXIDASE INHIBITORS POTENTIATE THE EFFECTS OF DEEP BRAIN STIMULATION. AMERICAN JOURNAL OF PSYCHIATRY. 2012;169(12):1320-13 21. DOI: 10.1176/APPI.AJP.2012.12060754. SUMMARY: THE AUTHORS PROVIDE CLINICAL AND PRECLINICAL EVIDENCE SUGGESTING THAT THE EFFECTS OF DBS MAY BE POTENTIATED BY THE CO-ADMINISTRATION OF MONOAMINE OXIDASE INHIBITORS (MAOIS). THE CASE STUDY HIGHLIGHTS THE EFFECTS ON A 35-YEAR-OLD MAN DIAGNOSED WITH DEPRESSION. REPORTED EVENT: A 35 YEAR OLD MALE EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOUR YEARS AFTER DBS IMPLANT. REPROGRAMMING DID NOT RESOLVE THE ISSUE. THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED WITHOUT A NOTICEABLE IMPROVEMENT IN DEPRESSION. THE PATIENT WAS GIVEN TRANYLCYPROMINE, 40 MG ORALLY, TWICE A DAY, ALONGSIDE DBS (2.5 V, 90 'S, 130 HZ,1- 5- C+). AFTER THE MEDICATION CHANGE, THE PATIENT'S DEPRESSION IMPROVED MARKEDLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54992 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Required Intervention