BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 23169328 · Received September 29, 2025

    Report

    Report Number
    3006630150-2025-08119
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    September 12, 2025
    Report Date
    September 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, BASED OFF BSC AWARE DATE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7127385, UNIQUE IDENTIFIER (UDI): (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7127705, UNIQUE IDENTIFIER (UDI): (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7140222, UNIQUE IDENTIFIER (UDI): (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7140327, UNIQUE IDENTIFIER (UDI): (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED TENDERNESS, REDNESS AND PURULENT DISCHARGE AT THE INCISION SITES ON THE HEAD. AFTER EXAMINATION, THE PHYSICIAN ASSESSED THAT THE PATIENT HAD AN INFECTION AND THE PATIENT WAS GIVEN ANTIBIOTIC MEDICATION AND A CULTURE WAS TAKEN. THE PHYSICIAN DECLINED TO PROVIDE BOSTON SCIENTIFIC WITH THE CULTURE RESULTS. ADDITIONALLY, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE DURING WHICH THE ENTIRE SYSTEM WAS REMOVED. THERE WERE NO REPORTED PATIENT COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1408979 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 785532

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention