BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 15737538 · Received November 4, 2022

    Report

    Report Number
    3006630150-2022-06012
    Event Type
    Injury
    Date Received
    November 4, 2022
    Date of Event
    October 14, 2022
    Report Date
    November 15, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: UNKNOWN LEAD; UPN: UNKNOWN; MODEL: UNKNOWN; SERIAL: UNKNOWN; BATCH: UNKNOWN.

    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)(6). BATCH: 7093975. PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7093914.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INCREASED FATIGUE, SPEECH AND WALKING DIFFICULTIES, AND EDEMA SURROUNDING THE LEFT LEAD FOLLOWING THE INITIAL PROGRAMMING APPOINTMENT APPROXIMATELY THREE WEEKS AFTER BEING IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WHERE STIMULATION WAS TURNED OFF, BRAIN IMAGING WAS DONE, AND LABS WERE DRAWN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED INCREASED FATIGUE, SPEECH AND WALKING DIFFICULTIES, AND EDEMA SURROUNDING THE LEFT LEAD FOLLOWING THE INITIAL PROGRAMMING APPOINTMENT APPROXIMATELY THREE WEEKS AFTER BEING IMPLANTED WITH THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WHERE STIMULATION WAS TURNED OFF, BRAIN IMAGING WAS DONE, AND LABS WERE DRAWN. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD A FOLLOW-UP APPOINTMENT WITH HER NEUROLOGIST WHERE THE DEVICE WAS REPROGRAMMED, AND THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178195 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1416 209520 08714729985020

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization