BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 21712802 · Received March 27, 2025

    Report

    Report Number
    3006630150-2025-01962
    Event Type
    Injury
    Date Received
    March 27, 2025
    Date of Event
    March 5, 2025
    Report Date
    March 27, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985020
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL PRO CODES NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7132916. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7131144.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED SWELLING AT THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSION SITE. CULTURES TAKEN TESTED POSITIVE FOR METHICILLIN-SENSITIVE STAPHYLOCOCCUS AUREUS (MSSA). THE PATIENT WAS PRESCRIBED ANTI-BIOTICS AND WAS SCHEDULED FOR REMOVAL OF DEVICES. IT WAS NOTED THAT THE PATIENT TOUCHED THE IPG INCISION SITE WITH DIRTY HANDS WHILE FARMING SOMETIME AFTER PROCEDURE, CAUSING THE INFECTION PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE THIRTEEN DAYS LATER WHERE THE IPG AND LEAD EXTENSIONS WERE REMOVED. PHYSICAL ANALYSIS OF THE DBS DEVICES WAS NOT PERFORMED AS THEY WERE DISCARDED BY THE FACILITY. THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2658653 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1416 230701 08714729985020

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Required Intervention