BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 11735581 · Received April 27, 2021

    Report

    Report Number
    3006630150-2021-01805
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    March 29, 2021
    Report Date
    May 27, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO BLOCK B5.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT BURR HOLE INCISION WAS OPEN AND PRODUCING DISCHARGE. IT WAS ASSESSED THAT THE PATIENT HAD AN INFECTION AND UNDERWENT AN EXPLANT PROCEDURE IN WHICH ALL DEVICES WERE EXPLANTED. THE EXPLANTED DEVICES WERE DISCARDED AND WERE NOT BE RETURNED FOR ANALYSIS. A CULTURE WAS TAKEN, BUT THE RESULTS ARE UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS, AND HAS RECOVERED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7072760. PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7075238. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0, MODEL: DB-4600C, BATCH: 26050826. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7083006. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7084234.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S RIGHT BURR HOLE INCISION WAS OPEN AND PRODUCING DISCHARGE. IT WAS ASSESSED THAT THE PATIENT HAD AN INFECTION AND UNDERWENT AN EXPLANT PROCEDURE IN WHICH ALL DEVICES WERE EXPLANTED. A CULTURE WAS TAKEN, BUT THE RESULTS ARE UNKNOWN. THE PATIENT WAS PLACED ON ANTIBIOTICS, AND HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626651 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 745157 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention