BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 13539784 · Received February 16, 2022

    Report

    Report Number
    3006630150-2022-00523
    Event Type
    Injury
    Date Received
    February 16, 2022
    Date of Event
    November 20, 2021
    Report Date
    February 16, 2022
    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)(4), LOT: 7070906.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER TEN MONTHS OF USE, THE DEEP BRAIN STIMULATION PATIENT EXPERIENCED HIS TREMOR SYMPTOMS RETURN. REPROGRAMMING THE DEVICE STIMULATION WAS ATTEMPTED, HOWEVER, THE ISSUE DID NOT RESOLVE. THE PHYSICIAN SUSPECTED THE LEADS TARGETED IN THE GLOBUS PALLIDUS INTERNA, GPI WERE NOT EFFECTIVELY CAPTURING THE PATIENTS WORSENING TREMOR. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEADS WERE REPLACED PER PHYSICIAN PREFERENCE AND TWO NEW LEADS WERE POSITIONED IN THE CAUDAL ZONA INCERTA, CZI. THE PATIENT WAS DOING WELL POST-OPERATIVELY WITH BETTER CONTROL OF HIS SYMPTOMS. THE LEADS WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472634 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-2201-45-DC 678169 08714729836544

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention