BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 16936796 · Received May 16, 2023

    Report

    Report Number
    3006630150-2023-02749
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    February 3, 2021
    Report Date
    May 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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: 7072148. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: N/A, BATCH: 25423581. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7075026.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE LOCATION AND CAUSE OF THE INFECTION IS NOT KNOWN, HOWEVER IT WAS DETERMINED NOT TO BE DEVICE RELATED OR RELATED TO THE PROCEDURE. THE PATIENT WAS PLACED ON ANTIBIOTICS FOLLOWING HE EXPLANT, A CULTURE WAS ALSO TAKEN HOWEVER THE RESULTS ARE UNKNOWN. THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474701 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 742943 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention