BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 18461017 · Received January 5, 2024

    Report

    Report Number
    3006630150-2023-08492
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    November 30, 2023
    Report Date
    January 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985020
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: 7100939; PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7100959; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7113610; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7113971; PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, BATCH: 31230143.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A CYST IN HIS BRAIN AND WAS HOSPITALIZED. IT IS UNKNOWN WHAT CONTRIBUTED TO THE CYST PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE WHERE ALL THE DBS DEVICES WERE EXPLANTED. PHYSICAL ANALYSIS OF THE DBS DEVICES WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY AND THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907397 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1416 216033 08714729985020

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Hospitalization| R