BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 23991911 · Received January 7, 2026

    Report

    Report Number
    3006630150-2026-00153
    Event Type
    Injury
    Date Received
    January 7, 2026
    Date of Event
    July 1, 2025
    Report Date
    January 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985051
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE IN THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. FOLLOWING A NON DEVICE RELATED INCIDENT, THE PATIENT SUSTAINED A LACERATION TO THE HEAD AFTER NICKING THE EXTENSION HEADER. THE SITE SUBSEQUENTLY BECAME RED AND SWOLLEN. THE WOUND DEVELOPED AN INFECTION, WHICH LATER EXTENDED TO OTHER COMPONENTS OF THE IMPLANTED SYSTEM, INCLUDING THE IMPLANTABLE PULSE GENERATOR (IPG) AREA. THE PATIENT WAS INITIATED ON ANTIBIOTICS. CULTURES WERE OBTAINED; HOWEVER, THE RESULTS WERE NOT PROVIDED. THE DEVICES WERE RETAINED BY THE HOSPITAL AND WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54160 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1232 767284 08714729985051

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention