BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 12094929 · Received June 30, 2021

    Report

    Report Number
    3006630150-2021-03364
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 9, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT(S) INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 5143645. PRODUCT FAMILY: DBS-LINEAR LEADS , UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 5138436. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7052740. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7052886.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATOR (DBS) SYSTEM WAS REMOVED DUE TO INFECTION AROUND THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PHYSICIAN IS UNCERTAIN WHETHER THE DEVICE MAY HAVE CAUSED THE INFECTION. THE PATIENT WAS IN GOOD HEALTH POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    988046 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 739145

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention