BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 11408967 · Received March 4, 2021

    Report

    Report Number
    3006630150-2021-00737
    Event Type
    Injury
    Date Received
    March 4, 2021
    Date of Event
    February 9, 2021
    Report Date
    March 3, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 5076611. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7071617.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING HEADACHES. MAGNETIC RESONANCE IMAGING (MRI) AND BLOOD WORK WERE NEGATIVE FOR INFECTION, FLUID, AND ALLERGIES. THE PATIENT WAS ADMINISTERED MEDICATION. THE PATIENT OBTAINED A SECOND OPINION AND THAT PHYSICIAN SUSPECTS THAT THE PATIENT MAY HAVE A CEREBRAL SPINAL FLUID LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305636 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 741353 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention