BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17936376 · Received October 13, 2023

    Report

    Report Number
    3006630150-2023-06250
    Event Type
    Injury
    Date Received
    October 13, 2023
    Date of Event
    August 15, 2023
    Report Date
    October 13, 2023
    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 UNKNOWN, EVENT OCCURRED BETWEEN (B)(6) 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5000962. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7080363. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(6), BATCH: 7080420. PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 31084869. PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 31359711.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD PURULENT DISCHARGE EXCRETING FROM THE DEEP BRAIN STIMULATION (DBS) NECK AND CHEST INCISION SITES. CULTURES WERE TAKEN CONFIRMED THE PRESENCE OF INFECTION; HOWEVER, THE SPECIFIC RESULTS WERE NOT PROVIDED. THE PATIENT WAS PRESCRIBED INTRAVENOUS (IV) ANTIBIOTICS AND SCHEDULED TO HAVE THE DBS SYSTEM REMOVED. THE FIRST OF TWO PROCEDURES REMOVED THE IMPLANTABLE PULSE GENERATOR (IPG) AND LEAD EXTENSION; AND A WEEK LATER, THE REMAINING LEADS AND BURR HOLE COVERS WERE REMOVED. PHYSICAL ANALYSIS COULD NOT BE PERFORMED IN OUR LABORATORY, AS THE DEVICES WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682712 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 576123 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention