BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 18298344 · Received December 9, 2023

    Report

    Report Number
    3006630150-2023-07737
    Event Type
    Injury
    Date Received
    December 9, 2023
    Date of Event
    November 3, 2023
    Report Date
    December 9, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729836544
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB220145DC0, MODEL: DB-2201-45-DC, SERIAL: (B)(6), BATCH: 7074051.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED BALANCE AND SPEECH DIFFICULTIES FOLLOWING A STANDARD BILATERAL DEEP BRAIN STIMULATION (DBS) LEAD PLACEMENT, AND A NERVE GRAFT INTO THE SUBSTANTIA NIGRA PARS RETICULATA. AN INVESTIGATIONAL METHOD FOR CANNULA INSERTION WAS USED FOR BOTH THE LEAD PLACEMENT AND THE NERVE GRAFTS, RESULTING IN A TEN-HOUR PROCEDURE. THE PHYSICIAN ASSESSED THAT THE PATIENT'S POSTOPERATIVE SYMPTOMS WERE DUE TO HAVING BEEN UNDER ANESTHESIA FOR A PROLONGED PERIOD OF TIME. THE PATIENT WAS ADMITTED TO THE HOSPITAL, AND WAS PROVIDED PHYSICAL THERAPY. THE PATIENT RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1770588 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-2201-45-DC 7073896 08714729836544

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention