BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 11508499 · Received March 17, 2021

    Report

    Report Number
    3006630150-2021-01045
    Event Type
    Injury
    Date Received
    March 17, 2021
    Date of Event
    February 23, 2021
    Report Date
    March 17, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL:DB-2202-45, SERIAL: (B)(4), BATCH: 7073119. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL:DB-2202-45 , SERIAL: (B)(4), BATCH: 7073127.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) SYSTEM TO HELP REDUCE PATIENT'S SYMPTOMS OF LEIGH'S SYNDROME. THE DBS SYSTEM DID NOT HELP SO THE PATIENT UNDERWENT AN EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405595 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 742695 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention