BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA?

    MDR report key: 22790118 · Received August 12, 2025

    Report

    Report Number
    3006630150-2025-06435
    Event Type
    Injury
    Date Received
    August 12, 2025
    Date of Event
    May 2, 2022
    Report Date
    August 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729984443
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7053508, UDI: (B)(4). PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7053526, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION, INTERMITTENT STIMULATION AND OVERSTIMULATION RANDOMLY WHEN THE DEVICE WAS TURNED ON. HIGH IMPEDANCE READINGS WERE DISCOVERED ON THE NON-BOSTON SCIENTIFIC LEFT LEAD HOWEVER IT COULD NOT BE DETERMINED IF THE HIGH IMPEDANCE CAME FROM THE NON-BOSTON SCIENTIFIC LEAD AND LEAD EXTENSION OR THE BOSTON SCIENTIFIC IPG AND ADAPTERS. THEREFORE, THE PATIENT UNDERWENT A REVISION PROCEDURE DURING WHICH THE BOSTON SCIENTIFIC IPG AND ADAPTERS WERE EXPLANTED AND REPLACED WITH A NON-BOSTON SCIENTIFIC IPG. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    814318 VERCISE GEVIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1200-S 738545 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention