BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA?

    MDR report key: 21851632 · Received April 16, 2025

    Report

    Report Number
    3006630150-2025-02525
    Event Type
    Injury
    Date Received
    April 16, 2025
    Date of Event
    August 1, 2024
    Report Date
    June 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EXPLANT PROCEDURE. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB220145DC0, MODEL: DB-2201-45DC, SERIAL: (B)(6), BATCH: 7070554, UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB220145DC0, MODEL: DB-2201-45DC, SERIAL: (B)(6), BATCH: 7070927, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7080449. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7080245, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AND SUFFERED A HEMATOMA. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL SYSTEM WAS EXPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AND SUFFERED A HEMATOMA. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL SYSTEM WAS EXPLANTED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE LOCATION OF THE INFECTION AND HEMATOMA WAS AT THE SITE OF THE IPG WHEREIN THERE WERE SYMPTOMS OF REDNESS, SWELLING AND PAIN PRESENT. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED. AN APPROXIMATION OF THE EVENT DATE WAS ALSO PROVIDED. THE PATIENT ALSO REPORTED THAT THE HEMATOMA WAS DUE TO AN UNRELATED ACCIDENT NOT DUE TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122714 VERCISE GEVIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1200-S 744528 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention