BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA?

    MDR report key: 21428483 · Received February 20, 2025

    Report

    Report Number
    3006630150-2025-00920
    Event Type
    Injury
    Date Received
    February 20, 2025
    Date of Event
    January 27, 2025
    Report Date
    May 19, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729984443
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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)(6), BATCH: 7075331. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7072475.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS IMPLANTABLE PULSE GENERATOR (IPG) MIGRATED TO THEIR CHEST, CREATING A SMALL HOLE. AS A RESULT, THE PATIENT DEVELOPED AN INFECTION, BELIEVED TO BE CAUSED BY THE IPG MIGRATION. THE IPG AND LEAD EXTENSIONS WERE REMOVED AND REPLACED. ALTHOUGH A CULTURE WAS TAKEN, THE RESULTS ARE UNKNOWN. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND IS RECOVERING WELL POSTOPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) MIGRATED TO THEIR CHEST, CREATING A SMALL HOLE. AS A RESULT, THE PATIENT DEVELOPED AN INFECTION, BELIEVED TO BE CAUSED BY THE IPG MIGRATION. THE IPG AND LEAD EXTENSIONS WERE REMOVED AND REPLACED. ALTHOUGH A CULTURE WAS TAKEN, THE RESULTS ARE UNKNOWN. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND IS RECOVERING WELL POSTOPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE RESULTS OF THE CULTURE CAME BACK NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347099 VERCISE GEVIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1200-S 742127 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1