BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 20287085 · Received September 23, 2024

    Report

    Report Number
    3006630150-2024-06369
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    September 5, 2024
    Report Date
    September 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE OF EVENT UNKNOWN. APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB312855B0 MODEL: DB-3128-55B SERIAL: (B)(6) BATCH: 5002981.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SWELLING AND REDNESS AT THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) SITE. CULTURES WERE TAKEN HOWEVER THE RESULTS ARE UNKNOWN. IT WAS NOTED THAT THE INFECTION WAS DEVICE RELATED PER THE PHYSICIAN'S ASSESSMENT, HOWEVER THE INFORMATION AS TO HOW IT WAS RELATED WAS NOT PROVIDED. THE PATIENT UNDERWENT A PROCEDURE WHERE THE IPG AND LEAD EXTENSION WERE REMOVED. PHYSICAL ANALYSIS OF THE DBS IPG AND LEAD EXTENSION WAS NOT PERFORMED AS THEY WERE RETAINED 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
    1289890 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 758267 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention