BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 24973689 · Received April 23, 2026

    Report

    Report Number
    3006630150-2026-02580
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    March 1, 2026
    Report Date
    May 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <NHL, PJS>. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: SC-9208-15 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7070932 MODEL/CATALOG DESCRIPTION: RECISION S8 ADAPTER 15CM UNIQUE IDENTIFIER (UDI) #: (B)(4). MODEL NUMBER/CATALOG NUMBER: SC-9208-15 SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7030767 MODEL/CATALOG DESCRIPTION: PRECISION S8 ADAPTER 15CM UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED AN EPIDERMOID CYST WITHIN THE SUBCUTANEOUS IMPLANTABLE PULSE GENERATOR (IPG) POCKET, WHICH CAUSED DISCOMFORT AND LOCALIZED PAIN. AS A RESULT, THE PATIENT UNDERWENT A SURGICAL REPOSITIONING PROCEDURE INVOLVING RELOCATION OF THE IPG AND ADAPTERS. THE IPG WAS MOVED TO THE LEFT CHEST TO ALLOW THE SURGEON TO RESECT THE MASS FROM THE RIGHT POCKET. POSTOPERATIVELY, THE PATIENTS THERAPY WAS RESUMED IMMEDIATELY WITHOUT INTERRUPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413532 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 559067 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention