BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 16936826 · Received May 16, 2023

    Report

    Report Number
    3006630150-2023-02751
    Event Type
    Injury
    Date Received
    May 16, 2023
    Date of Event
    July 27, 2021
    Report Date
    July 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    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-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7085480 AND 7087270. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7080126.

    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: 7085480 AND 7087270.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE LOCATION AND CAUSE OF THE INFECTION IS NOT KNOWN, AND IT IS UNKNOWN IF IT IS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS FOLLOWING THE EXPLANT, A CULTURE WAS ALSO TAKEN HOWEVER THE RESULTS ARE UNKNOWN. THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY WERE RETAINED BY THE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT A SECOND LEAD WAS EXPLANTED DURING THE PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE IN WHICH THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE LOCATION AND CAUSE OF THE INFECTION IS NOT KNOWN, AND IT IS UNKNOWN IF IT IS DEVICE OR PROCEDURE RELATED. THE PATIENT WAS PLACED ON ANTIBIOTICS FOLLOWING HE EXPLANT, A CULTURE WAS ALSO TAKEN HOWEVER THE RESULTS ARE UNKNOWN. THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474716 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 508094 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention