BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 19602085 · Received June 24, 2024

    Report

    Report Number
    3006630150-2024-04055
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    May 22, 2024
    Report Date
    June 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7080878. PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7080667. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0, MODEL: DB-4600C, BATCH: 26729874. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0, MODEL: DB-4600C, BATCH: 26850482. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7083269. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7083506.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED OPENING OF THE SKIN OVER THE IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT INDICATED HAVING A PIMPLE THAT WAS POPPED OVER THE IMPLANT AND IT NEVER HEALED. THE PATIENT UNDERWENT A SYSTEM EXPLANT AND WAS DOING WELL POST-OPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1104324 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 745878 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention