BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 15521172 · Received September 30, 2022

    Report

    Report Number
    3006630150-2022-05171
    Event Type
    Injury
    Date Received
    September 30, 2022
    Date of Event
    December 1, 2019
    Report Date
    September 30, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(4). LOT: 5177205. PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(4). LOT: 5177301. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550. MODEL: NM-3138-55 7059969. SERIAL: (B)(4). LOT: 7059969. PRODUCT FAMILY: DBS-EXTENSION: UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(4). LOT: 7060354. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: N/A. LOT: 24474550. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: N/A. LOT: 24524518.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A RARE BACTERIAL INFECTION. THE SYMPTOMS WERE REDNESS AND PUSS AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE IN THE CHEST AND AT THE DEEP BRAIN STIMULATION LEAD SITE IN THE HEAD. ADDITIONALLY, FINGERNAIL MARKS WERE FOUND ON AND AROUND THE IPG SITE AND INDICATED THE PATIENT HAD BEEN PICKING. THE PATIENT INITIALLY UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG AND LEAD EXTENSIONS WERE REMOVED. IT WAS THEN FOUND THAT THIS INFECTION WAS ALSO LOCATED AT THE LEAD SITES AND THEREFORE, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE SEVERAL DAYS LATER TO REMOVE THE LEADS AND BURR HOLE COVERS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. IT WAS NOTED THAT ANTIBIOTICS HAD BEEN ADMINISTERED AT THE TIME OF IMPLANT, HOWEVER, IT WAS UNKNOWN IF OR WHAT MEDICATION MAY HAVE BEEN ADMINISTERED AFTER. THE PHYSICIAN FURTHER ASSESSED THE INFECTION WAS NOT DEVICE RELATED AND THAT THE PATIENT MAY HAVE BEEN IMPLANTED TOO SOON AFTER THE FIRST INFECTION (MFR. 3006630150-2019-02593). THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2336792 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 740268 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention| O