BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 20429262 · Received October 11, 2024

    Report

    Report Number
    3006630150-2024-06865
    Event Type
    Injury
    Date Received
    October 11, 2024
    Date of Event
    July 2, 2024
    Report Date
    October 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300 MODEL: DB-2202-30 SERIAL: (B)(6) BATCH: 7082272 . PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202300 MODEL: DB-2202-30 SERIAL: (B)(6) BATCH: 7081838. PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB312855B0 MODEL: DB-3128-55B SERIAL: (B)(6). BATCH: 5002551. PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C BATCH: 33572841 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C BATCH: 32697195.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED AN INFECTION ON THEIR SCALP AND WAS EXPERIENCING PURULENT DISCHARGE. THE PATIENT HAD THEIR ENTIRE SYSTEM EXPLANTED. A CULTURE WAS TAKEN THAT REVEALED THAT THE PATIENT HAD DEVELOPED STAPHYLOCOCCUS AUREUS. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY. THE DEVICES WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335271 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 590467 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention