BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 22681306 · Received July 31, 2025

    Report

    Report Number
    3006630150-2025-06043
    Event Type
    Injury
    Date Received
    July 31, 2025
    Date of Event
    July 8, 2025
    Report Date
    July 31, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCKB3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: PJS, NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202300. MODEL: DB-2202-30. SERIAL: (B)(4). BATCH: 7073260. UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202300. MODEL: DB-2202-30. SERIAL: (B)(6). BATCH: 7072232. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A SYSTEM EXPLANT BECAUSE THE THERAPY DID NOT EFFECTIVELY TREAT THE PATIENT'S SYMPTOMS, WHICH INCLUDED UNCONTROLLABLE MUSCLE MOVEMENT. THE PATIENT IS DOING GOOD POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS, AS THEY WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197680 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 513034 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention