BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 11499983 · Received March 17, 2021

    Report

    Report Number
    3006630150-2021-01025
    Event Type
    Injury
    Date Received
    March 17, 2021
    Date of Event
    February 10, 2021
    Report Date
    April 20, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT, WHO IS ENROLLED IN THE VERCISE DBS REGISTRY CLINICAL TRIAL, DEVELOPED MODERATE DYSPHAGIA AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS TREATED WITH MEDICATION. THE DEVICE WAS REPROGRAMMED, A VIDEOFLUOROSCOPIC SWALLOW STUDY TEST AND AN L-TUBE FEEDING WAS PERFORMED. THE PATIENT IS RECOVERING AND THE EVENT IS RESOLVING. THE EVENT WAS ASSESSED AS HAVING A CAUSAL RELATIONSHIP TO THE STIMULATION, AN UNLIKELY RELATIONSHIP TO HARDWARE, AND NOT RELATED TO THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE PATIENTS YEAR OF BIRTH IS (B)(6), THE EXACT DATE IS UNKNOWN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450 , MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 5181018. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450 , MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7070157.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED MODERATE DYSPHAGIA AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT WAS TREATED WITH MEDICATION. THE DEVICE WAS REPROGRAMMED, A VIDEOFLUOROSCOPIC SWALLOW STUDY TEST AND AN L-TUBE FEEDING WAS PERFORMED. THE PATIENT IS RECOVERING AND THE EVENT IS RESOLVING. THE EVENT WAS ASSESSED AS HAVING A CAUSAL RELATIONSHIP TO THE STIMULATION, AN UNLIKELY RELATIONSHIP TO HARDWARE, AND NOT RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398624 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 740973

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention