BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 22690504 · Received August 1, 2025

    Report

    Report Number
    3006630150-2025-06088
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    June 27, 2025
    Report Date
    August 1, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, SYMPTOMS HAVE NOT IMPROVED SINCE SURGERY DATE ON (B)(6) 2025. BLOCK D.2B; ADDITIONAL APPLICABLE PRODUCT CODES: NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5003965, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED PERSISTENT REDNESS AND WARMTH AT THE IMPLANTABLE PULSE GENERATOR (IPG) INCISION SITE FOLLOWING THE MOST RECENT SURGERY. DUE TO CONCERNS ABOUT A POTENTIAL INFECTION, THE PATIENT WAS TAKEN TO THE OPERATING ROOM FOR EVALUATION. INTRAOPERATIVELY, NO VISIBLE SIGNS OF INFECTION WERE OBSERVED; HOWEVER, THE IPG POCKET WAS WASHED WITH ANTIBIOTIC FLUID AND CULTURES WERE OBTAINED. THE CULTURES LATER RETURNED POSITIVE. CONSEQUENTLY, THE IPG AND THE LEAD EXTENSION WERE EXPLANTED, AND THE PATIENT WAS PLACED ON ANTIBIOTICS. ACCORDING TO THE PHYSICIAN, THE INFECTION IS NOT RELATED TO THE DEVICE. THE PATIENT IS RECOVERING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR ANALYSIS, AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050252 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 785074 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention