BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 9751160 · Received February 25, 2020

    Report

    Report Number
    3006630150-2020-00774
    Event Type
    Injury
    Date Received
    February 25, 2020
    Date of Event
    January 20, 2020
    Report Date
    March 27, 2020
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO INITIAL MDR IN SECTION B5.

    Description of Event or Problem · 0

    A REPORT WAS RECEIVED THAT A PATIENT ENROLLED IN THE VERCISE DBS DYSTONIA REGISTRY STUDY (B)(6) EXPERIENCED FRONTAL BILATERAL PROXIMAL PERI-LEAD EDEMA 5 DAYS POST-IMPLANT. MEDICATION WAS ADMINISTERED AND THE EDEMA WAS RESOLVING. PATIENT WAS IN GOOD CLINICAL CONDITION POST MEDICAL INTERVENTION. THE EDEMA WAS ASSESSED TO BE RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE OR STIMULATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 5173747.

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED THAT A PATIENT ENROLLED IN THE (B)(6) STUDY A4012 EXPERIENCED FRONTAL BILATERAL PROXIMAL PERI-LEAD EDEMA 5 DAYS POST-IMPLANT. MEDICATION WAS ADMINISTERED AND THE EDEMA WAS RESOLVING. PATIENT WAS IN GOOD CLINICAL CONDITION POST MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214770 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 5150009 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention