BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 20364764 · Received October 3, 2024

    Report

    Report Number
    3006630150-2024-06624
    Event Type
    Injury
    Date Received
    October 3, 2024
    Date of Event
    September 10, 2024
    Report Date
    October 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5003228.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A FALL AND HITTING HIS LEFT SIDE OF THEIR HEAD WHICH CAUSED A BRAIN BLEED SEVERAL DAYS AFTER STAGE ONE IMPLANT. IT WAS NOTED THAT THE DBS DEVICE WAS NOT YET ACTIVATED, AND THE PATIENT HAS HAD POOR BALANCE ISSUES AND BAD DYSKINESIA RELATED TO THEIR PARKINSON'S DISEASE PRIOR TO IMPLANTATION. THE PATIENT UNDERWENT A CRANIOTOMY PROCEDURE WHERE THE BLEEDING WAS ADDRESSED BEFORE COMPLETING THE PROCEDURE. THE DBS LEAD AND LEAD EXTENSION REMAIN IMPLANTED. THE PATIENT DID WELL POST-OPERATIVELY. NO FURTHER INFORMATION HAS BEEN OBTAINED DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1403555 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7124238 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Male Required Intervention| H