BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 21258637 · Received January 28, 2025

    Report

    Report Number
    3006630150-2025-00251
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    January 3, 2025
    Report Date
    January 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729984443
    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-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 5175054. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 5179973. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 5172969. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 5162928.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A RETURN OF THEIR DYSTONIA DUE TO HIGH IMPEDANCES ON THE LEFT LEAD EXTENSION AND VARYING IMPEDANCES ON THE RIGHT LEAD EXTENSION. TO ADDRESS THIS, THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE IMPLANTABLE PULSE GENERATOR (IPG) AND ONE OF THE LEAD EXTENSIONS WERE REPLACED, WHILE THE OTHER LEAD EXTENSION WAS REMOVED. DESPITE THESE CHANGES, THE SYSTEM STILL SHOWED IMPEDANCE ISSUES, BUT THEY WERE IN CONTACTS NOT USED BY THE PATIENT. AS A RESULT, THE PATIENT IS RECEIVING THERAPY AS EXPECTED. THE EXPLANTED DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2405024 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1200-S 740614 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Required Intervention