BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 17221507 · Received June 28, 2023

    Report

    Report Number
    3006630150-2023-03725
    Event Type
    Injury
    Date Received
    June 28, 2023
    Date of Event
    June 13, 2023
    Report Date
    December 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905196
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-ADAPTERS UPN: M365DB9218150, MODEL: DB-9218-15, SERIAL: (B)(6), BATCH: 7073352.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) CLINICAL PATIENT ENROLLED IN (B)(6) STUDY EXPERIENCED A MODERATE WORSENING OF PARKINSON SYMPTOMS OF RIGIDITY AND BRADYKINESIA ON THE RIGHT SIDE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE DEVICE WAS REPROGRAMMED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE DBS POCKET ADAPTERS WERE REPLACED. THE EVENT HAS RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) CLINICAL PATIENT ENROLLED IN A4010 STUDY EXPERIENCED A MODERATE WORSENING OF PARKINSON SYMPTOMS OF RIGIDITY AND BRADYKINESIA ON THE RIGHT SIDE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND THE DEVICE WAS REPROGRAMMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1543045 VERCISE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-9218-15 7073557 08714729905196

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention