BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 12037360 · Received June 21, 2021

    Report

    Report Number
    3006630150-2021-03102
    Event Type
    Injury
    Date Received
    June 21, 2021
    Date of Event
    May 28, 2021
    Report Date
    July 8, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB220145DC, MODEL: DB-2201-45-DC, SERIAL: (B)(6) , BATCH: 7070780 . PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB220145DC, MODEL: DB-2201-45-DC, SERIAL: (B)(6) , BATCH: 7070784.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ARM AND LEG PAIN AS WELL AS INVOLUNTARY JERKING OF THE ARMS. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS INFORMED HOW TO TURN OFF THE DEEP BRAIN SIMULATION (DBS) TO RULE OUT THE DEVICE AS A CONTRIBUTING FACTOR. THE PATIENT WAS ADMITTED AND EVALUATED BY THE NEUROLOGY TEAM. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED TWO SMALL AREAS OF HEMATOMA AT THE SURFACE OF THE BRAIN. THE PATIENT WAS TRANSFERRED TO A REHABILITATION CENTER AND DISCHARGED. THE NEUROLOGIST DOES NOT THINK THAT THE BRAIN BLEED WAS RELATED TO THE DBS IMPLANT SURGERY SINCE THE BLOOD NOTED ON THE SCAN WAS CONSIDERED RECENT, WITHIN 24-48 HOURS, AND WAS LIKELY THE RESULT OF A FALL AT HOME. THE DBS WAS TURNED ON AND SIGNIFICANTLY IMPROVED THE PATIENTS TREMOR. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PHYSICIAN DID NOT BELIEVE THE HEMATOMAS WERE DEVICE OR PROCEDURE RELATED. THE HEMATOMAS WERE LIKELY THE RESULT OF A FALL THAT THE PATIENT SUSTAINED SEVERAL WEEKS AFTER HIS SURGERY. THE PATIENT'S ARM AND LEG PAIN WAS MOSTLY RESOLVED AT THE LAST FOLLOW-UP VISIT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: (B)(4). MODEL: DB-2201-45-DC SERIAL: (B)(4). BATCH: N/I.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING ARM AND LEG PAIN AS WELL AS INVOLUNTARY JERKING OF THE ARMS. THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS INFORMED HOW TO TURN OFF THE DEEP BRAIN SIMULATION (DBS) TO RULE OUT THE DEVICE AS A CONTRIBUTING FACTOR. THE PATIENT WAS ADMITTED AND EVALUATED BY THE NEUROLOGY TEAM. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED TWO SMALL AREAS OF HEMATOMA AT THE SURFACE OF THE BRAIN. THE PATIENT WAS TRANSFERRED TO A REHABILITATION CENTER AND DISCHARGED. THE NEUROLOGIST DOES NOT THINK THAT THE BRAIN BLEED WAS RELATED TO THE DBS IMPLANT SURGERY SINCE THE BLOOD NOTED ON THE SCAN WAS CONSIDERED RECENT, WITHIN 24-48 HOURS, AND WAS LIKELY THE RESULT OF A FALL AT HOME. THE DBS WAS TURNED ON AND SIGNIFICANTLY IMPROVED THE PATIENTS TREMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    927559 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 745022 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization