BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 17386289 · Received July 24, 2023

    Report

    Report Number
    3006630150-2023-04314
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    March 1, 2021
    Report Date
    July 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: 5169298. PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL:(B)(6); BATCH: 7071247. PRODUCT FAMILY: DBS-EXTENSION; UPN:M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); BATCH: 5177941. PRODUCT FAMILY: DBS-EXTENSION; UPN:M365NM3138550; MODEL: NM-3138-55; SERIAL:(B)(6); BATCH: 5178077.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION AT THE LEAD EXTENSION SITE. THE PATIENT EXPERIENCED A RED INCISION SITE AND WAS ADMINISTERED ANTIBIOTICS. THE PHYSICIAN COULD NOT DETERMINE THE CAUSE OF THE INFECTION. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598532 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 740307 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male Required Intervention