BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 11822032 · Received May 13, 2021

    Report

    Report Number
    3006630150-2021-02108
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 22, 2021
    Report Date
    May 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), LOT: 7080382.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A DEEP BRAIN STIMULATOR DBS LEAD IMPLANT PROCEDURE, A POST-OPERATIVE CONTINUOUS TOMOGRAPHY SCAN REVEALED THAT THE PATIENTS RIGHT LEAD MIGRATED 15 MILLIMETERS DEEPER. THE PHYSICIAN ASSESSED THAT DURING THE CRANIAL FIXATION PROCESS TO SECURE THE LEAD, THE LEAD SOMEHOW MIGRATED DEEPER. THERE WERE NO SYMPTOMS DUE TO THE LEAD MIGRATION, HOWEVER, THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE THE LEAD WAS REPLACED. THE PATIENT WAS DOING WELL POST-OPERATIVELY. THE LEAD WILL NOT BE RETURNED AS IT WAS DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714539 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7079431 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention