BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 18961596 · Received March 22, 2024

    Report

    Report Number
    3006630150-2024-01701
    Event Type
    Injury
    Date Received
    March 22, 2024
    Date of Event
    October 1, 2019
    Report Date
    March 22, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    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: 7060735 PRODUCT FAMILY: DBS-ADAPTERS UPN: M365DB9218150 MODEL: DB-9218-15 SERIAL: (B)(6). BATCH: 7060739.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A LACK OF TREMOR CONTROL SINCE BEING IMPLANTED. IT WAS NOTED THAT THE PATIENT HAD A MIXED SYSTEM THAT HAD NON-BOSTON LEADS. HIGH IMPEDANCE MEASUREMENTS WERE OBSERVED, AND REPROGRAMMING ATTEMPTS WERE UNSUCCESSFUL. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE ENTIRE SYSTEM AND DID WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    533451 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 739878 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention