BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17243124 · Received June 30, 2023

    Report

    Report Number
    3006630150-2023-03816
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    June 6, 2023
    Report Date
    June 30, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7101836. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7103295. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7106574. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7113613.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED REDNESS AND SWELLING AT THE CHEST INCISION, AND THE INCISION MADE TO CONNECT THE EXTENSIONS TO THE LEADS. CULTURES WERE TAKEN, BUT RESULTS WERE NOT RELEASED BY THE PHYSICIAN. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS REMOVED. PHYSICAL ANALYSIS OF THE EXPLANTED DEVICES COULD NOT BE PERFORMED IN OUR LABORATORY, AS THE DEVICES WERE SENT OUT FOR CULTURES BY THE FACILITY AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22522 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 568191 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Female Required Intervention