BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 20614124 · Received November 5, 2024

    Report

    Report Number
    3006630150-2024-07592
    Event Type
    Injury
    Date Received
    November 5, 2024
    Date of Event
    October 14, 2024
    Report Date
    November 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729985020
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7130129. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7124599. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7129878. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7130118.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE IMPLANTABLE PULSE GENERATOR (IPG) AND EXTENSIONS DUE TO EROSION. THE DEVICES WILL NOT BE RETURNED AS THEY WERE KEPT BY THE MEDICAL FACILITY. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428875 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1416 212882 08714729985020

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention