BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 8735792 · Received June 26, 2019

    Report

    Report Number
    3006630150-2019-03051
    Event Type
    Injury
    Date Received
    June 26, 2019
    Date of Event
    March 25, 2019
    Report Date
    September 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: DB-2202-30, SERIAL/LOT: (B)(4), DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 30 CM. MODEL: DB-2202-30, SERIAL/LOT: (B)(4), DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 30 CM. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR THE IPG (DB-1200, SERIAL NUMBER: (B)(4)) AND LEADS (DB-2202-30, SERIAL NUMBER: (B)(4)) REVEALED THAT NO ANOMALIES OR DEVIATIONS POTENTIALLY RELATED TO THE EVENT OCCURRED DURING MANUFACTURING.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED WORSENING OF GAIT, WHICH WAS MODERATE IN SEVERITY. THE PATIENT WAS ADMITTED TO THE HOSPITAL THE SAME DAY AND THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS DISCHARGED AFTER A WEEK. THE PHYSICIAN ASSESSED THE EVENT AS RECOVERED/RESOLVED WITH A POSSIBLE RELATIONSHIP TO STIMULATION. THE PHYSICIAN ALSO ASSESSED THAT THE EVENT WAS NOT RELATED TO THE PROCEDURE AND HARDWARE.

    Additional Manufacturer Narrative · 1

    DATE OF BIRTH: (B)(6); EXACT DATE OF BIRTH IS UNKNOWN. IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED AND IN SERVICE; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT THE PATIENT EXPERIENCED WORSENING OF GAIT, WHICH WAS MODERATE IN SEVERITY. THE PATIENT WAS ADMITTED TO THE HOSPITAL THE SAME DAY AND THE DEVICE WAS REPROGRAMMED. THE PATIENT WAS DISCHARGED AFTER A WEEK. THE PHYSICIAN ASSESSED THE EVENT AS RECOVERED/RESOLVED WITH A POSSIBLE RELATIONSHIP TO STIMULATION. THE PHYSICIAN ALSO ASSESSED THAT THE EVENT WAS NOT RELATED TO THE PROCEDURE AND HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530076 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 737199

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R