BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 18647875 · Received February 5, 2024

    Report

    Report Number
    3006630150-2024-00497
    Event Type
    Injury
    Date Received
    February 5, 2024
    Date of Event
    October 9, 2023
    Report Date
    February 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT UNKNOWN. APPROXIMATED (B)(6) 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7072239; PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7072268; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7086050; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7087035.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AT THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT SITE. THE IPG IMPLANT SITE WAS INFECTED, HOWEVER CULTURES WERE NOT TAKEN TO CONFIRM INFECTION. IT WAS NOTED THAT THE DEVICE NOR PROCEDURE CAUSED THE INFECTION PER THE PHYSICIANS ASSESSMENT, HOWEVER, THE CAUSE IS UNKNOWN. THE PATIENT UNDERWENT A PROCEDURE WHERE THE DBS IPG, LEADS AND LEAD EXTENSIONS WERE REMOVED. PHYSICAL ANALYSIS OF THE DBS DEVICES WAS NOT PERFORMED AS THEY WERE DISPOSED BY THE FACILITY. THE PATIENT WAS PRESCRIBED ANTI-BIOTICS AND DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482057 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 503166 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention