BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 13046239 · Received December 20, 2021

    Report

    Report Number
    3006630150-2021-07150
    Event Type
    Injury
    Date Received
    December 20, 2021
    Date of Event
    August 9, 2021
    Report Date
    January 24, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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)(4), BATCH: 7073540. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202300, MODEL: DB-2202-30, SERIAL: (B)(4), BATCH: 7071266.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO MODERATE COGNITIVE DECLINE. THE PATIENT WAS TREATED WITH MEDICATION, UNDERWENT A REVISION PROCEDURE, AND HAD THEIR DEVICE REPROGRAMMED. THE PATIENT WAS THEN DISCHARGED BUT THE OUTCOME IS UNKNOWN. THE PHYSICIAN ASSESSED THE EVENT AS NOT RELATED TO PROCEDURE AND DEVICE HARDWARE, BUT CAUSALLY RELATED TO DEVICE STIMULATION. ADDITIONAL INFORMATION WAS RECEIVED THAT THE REVISION PROCEDURE WAS PERFORMED BECAUSE THE PATIENT FELT THAT STIMULATION WITH HIGHER CURRENT ON THE LEFT SIDE WAS LEADING TO THE COGNITIVE DYSFUNCTION. DURING THE REVISION PROCEDURE, THE LEAD WAS PULLED BACK BY 2.5 CONTACTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO MODERATE COGNITIVE DECLINE. THE PATIENT WAS TREATED WITH MEDICATION, UNDERWENT A REVISION PROCEDURE, AND HAD THEIR DEVICE REPROGRAMMED. THE PATIENT WAS THEN DISCHARGED BUT THE OUTCOME IS UNKNOWN. THE PHYSICIAN ASSESSED THE EVENT AS NOT RELATED TO PROCEDURE AND DEVICE HARDWARE, BUT CAUSALLY RELATED TO DEVICE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1945903 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-1200 742711

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention