BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 18822569 · Received March 1, 2024

    Report

    Report Number
    3006630150-2024-01125
    Event Type
    Injury
    Date Received
    March 1, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7099889; PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7100241; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7099681; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7099996; PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 30357430.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION IN THE SCALP AREA AND AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS REMOVED. THE PATIENT WAS ADMINISTERED ORAL ANTIBIOTICS. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    112622 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 545564 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention