BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 16502381 · Received March 8, 2023

    Report

    Report Number
    3006630150-2023-01122
    Event Type
    Injury
    Date Received
    March 8, 2023
    Date of Event
    January 1, 2023
    Report Date
    March 8, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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: (B)(4), MODEL: DB-2201-45-DC SERIAL: (B)(4), BATCH: 5168323. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2201-45-DC, SERIAL: (B)(4), BATCH: 5173759. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7082801. PRODUCT FAMILY: DBS-EXTENSION, UPN: (B)(4), MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7082795.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A LACK OF BENEFIT WHILE UTILIZING THE THERAPY. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS REMOVED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164118 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 502733 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Female Required Intervention