BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 20582516 · Received October 31, 2024

    Report

    Report Number
    3006630150-2024-07455
    Event Type
    Injury
    Date Received
    October 31, 2024
    Date of Event
    October 7, 2024
    Report Date
    October 31, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729985051
    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: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7106975 PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7107998 PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7108344 PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6). BATCH: 7108540 PRODUCT FAMILY: BS-EXTENSION UPN: M365DB312895B0 MODEL: DB-3128-95B SERIAL: (B)(6). BATCH: 5000122 PRODUCT FAMILY: BS-EXTENSION UPN: M365DB312895B0 MODEL: DB-3128-95B SERIAL: (B)(6). BATCH: 5000244 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 33079329 PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 33133638.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION, HOWEVER THE LOCATION ON WHICH IMPLANT SITE IS INFECTED WAS NOT PROVIDED. THE PATIENT UNDERWENT A PROCEDURE WHERE THE ENTIRE DBS SYSTEM WAS REMOVED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1983008 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1232 759319 08714729985051

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female Required Intervention