BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 18937698 · Received March 19, 2024

    Report

    Report Number
    3006630150-2024-01615
    Event Type
    Injury
    Date Received
    March 19, 2024
    Date of Event
    February 1, 2024
    Report Date
    March 19, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7101211; PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7102073; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7123088; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7122872; PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 30731076; PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 30994075.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE SITE OF THE LEAD AND LEAD EXTENSION SITES, WHEREIN THERE WAS VISIBLE DRAINAGE COMING FROM THE SITES. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND ADMINISTERED IV ANTIBIOTICS. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICES WERE DISCARDED AT THE FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486999 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 588280 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention| H