BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 14757979 · Received June 21, 2022

    Report

    Report Number
    3006630150-2022-03036
    Event Type
    Injury
    Date Received
    June 21, 2022
    Date of Event
    June 6, 2022
    Report Date
    June 21, 2022
    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
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(4); BATCH: 5130752.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HIT HER HEAD MULTIPLE TIMES AFTER SUFFERING FROM NON-DEVICE RELATED FALLS AS THE STIMULATION HAD BEEN OFF. THE PATIENT WENT TO THE HOSPITAL WHERE IT WAS THOUGHT SHE COULD HAVE A POTENTIAL BRAIN BLEED OR POTENTIALLY THE LEADS COULD BE BROKEN. THE HOSPITAL STAFF DISCUSSED OBTAINING A CT SCAN BUT THE PATIENT DID NOT HAVE ONE AT THIS TIME. THE PATIENT CALLED A BSC REPRESENTATIVE, WHO WALKED THE PATIENT THROUGH RESTORING PROGRAMS ON THE REMOTE CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598321 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7073805 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| O