BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 19505717 · Received June 10, 2024

    Report

    Report Number
    3006630150-2024-03737
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    April 2, 2024
    Report Date
    June 10, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5002509.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED REDNESS AND SWELLING AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. IT IS UNKNOWN IF CULTURES WERE TAKEN, BUT THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE IPG AND EXTENSION WERE REMOVED. THE PATIENT DID WELL POSTOPERATIVELY. PHYSICAL ANALYSIS WAS NOT CONDUCTED IN OUR LABORATORY, AS THE DEVICES WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2055216 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 590823 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention