BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 17731100 · Received September 12, 2023

    Report

    Report Number
    3006630150-2023-05492
    Event Type
    Injury
    Date Received
    September 12, 2023
    Date of Event
    August 15, 2023
    Report Date
    September 12, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7093470. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. BATCH: 29238912 AND 29206283.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED INADEQUATE THERAPY, VERY LITTLE TREMOR CONTROL, DUE TO THE SUBOPTIMAL PLACEMENT OF THE LEFT DEEP BRAIN STIMULATION (DBS) LEAD. THE PATIENT UNDERWENT A REVISION PROCEDURE IN WHICH THE LEAD WAS REPLACED WITH A NEW LEAD, MALFUNCTION WAS NOT SUSPECTED. THE LOCKING MECHANISM ON THE BURR HOLE COVER WAS ALSO REPLACED. IT IS UNCLEAR WHICH OF THE TWO LEADS AND TWO BURR HOLE COVER WAS REPLACED. THE DEVICES WERE RETAINED BY THE FACILITY AND WILL NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173817 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7093429 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention