BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 12910199 · Received December 1, 2021

    Report

    Report Number
    3006630150-2021-06851
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    May 1, 2021
    Report Date
    December 1, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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)(4), BATCH: 7073608. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7073609. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7071229. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450 , MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7071261.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD THEIR DEEP BRAIN STIMULATION SYSTEM EXPLANTED DUE TO AN INFECTION AT THE INCISION SITE BEHIND THE EAR. THE PATIENT PRESENTED WITH EROSION WHICH WAS ASSESSED THAT IT MAY HAVE BEEN DUE TO THE PATIENT'S GLASSES RUBBING AGAINST THE INCISION. THE PATIENT WAS LATER RE-IMPLANTED WITH THE DEEP BRAIN STIMULATION SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1812263 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 740961 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention