BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 17208029 · Received June 27, 2023

    Report

    Report Number
    3006630150-2023-03667
    Event Type
    Injury
    Date Received
    June 27, 2023
    Date of Event
    August 11, 2020
    Report Date
    June 27, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY DBS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL-LOT: (B)(6), BATCH: 7072071 AND 7072169. PRODUCT FAMILY DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL-LOT: (B)(6), BATCH 7074607 AND 7075109.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RECENTLY IMPLANTED PATIENT EXPERIENCED REDNESS AND INFLAMMATION AT THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PATIENT UNDERWENT AN EXPLANT OF THE ENTIRE DBS SYSTEM. THE PHYSICIAN ASSESSED THAT THE INFECTION WAS NOT DEVICE RELATED AND DOES NOT KNOW IF IT WAS PROCEDURE RELATED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE FACILITY. THE PATIENT HAS RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1478123 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 742667 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention