BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17128462 · Received June 14, 2023

    Report

    Report Number
    3006630150-2023-03401
    Event Type
    Injury
    Date Received
    June 14, 2023
    Date of Event
    April 1, 2023
    Report Date
    June 14, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7110342. PRODUCT FAMILY: DBS-ADAPTERS, UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7075043.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE SITE OF THE IMPLANTABLE PULSE GENERATOR (IPG) AFTER THE IPG WAS IMPLANTED. THE PATIENT WAS ADMINISTERED ORAL ANTIBIOTICS; HOWEVER, THE PATIENT SYMPTOMS HAD WORSENED, AND PATIENT WAS EXPERIENCING PAIN, REDNESS AND SWELLING. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG AND THE DBS EXTENSIONS WERE REMOVED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE DEVICES WERE RETAINED AT THE FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945859 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 564768 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention