BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 22986825 · Received September 5, 2025

    Report

    Report Number
    3006630150-2025-07290
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    August 17, 2025
    Report Date
    September 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985051
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THE DEVICE <NHL>. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5003071, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5000999, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5000918, UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600-C SERIAL: (B)(6), BATCH: 34117943 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WENT TO THE EMERGENCY ROOM DUE TO A SKIN INFECTION AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE LOCATED IN THE CHEST. IT COULD NOT BE CONFIRMED IF THE INFECTION WAS ISOLATED TO THE CHEST OR IF IT TRAVELED TO THE LEAD EXTENSIONS INFECTING THE LEADS AS WELL. THEREFORE, THE PATIENT WAS PLACED ON ANTIBIOTICS AND UNDERWENT A FULL SYSTEM EXPLANT PROCEDURE. A CULTURE WAS TAKEN; HOWEVER, THE RESULTS WERE UNABLE TO BE OBTAINED. THE PATIENT WAS RECOVERING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DESTROYED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237604 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1232 766853 08714729985051

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Hospitalization| R