BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 20967226 · Received December 18, 2024

    Report

    Report Number
    3006630150-2024-08857
    Event Type
    Injury
    Date Received
    December 18, 2024
    Date of Event
    March 7, 2024
    Report Date
    December 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODE SELECTIONS THAT APPLY TO THE INDICATION OF THIS DEVICE - MHY. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7122818. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. BATCH: 33162393.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT NEVER RECEIVED ANY RELIEF OF HIS LEFT ARM TREMOR SYMPTOMS DUE TO WHERE THE LEAD WAS ORIGINALLY PLACED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE RIGHT BRAIN LEAD, LEAD EXTENSION AND BURR HOLE COVER WERE REPLACED. THE EXPLANTED DEVICES WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2082500 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7116367

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention