BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 16989080 · Received May 23, 2023

    Report

    Report Number
    3006630150-2023-02890
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    May 17, 2023
    Report Date
    May 23, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(4). LOT: 7071218. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(4). LOT: 7107681. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(4). LOT: 7106783. PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(4). LOT: 514345.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN ALLERGIC REACTION TO THE DEEP BRAIN STIMULATION (DBS) DEVICES. AS A RESULT, THE IMPLANT INCISIONS BLED AND SCABBED, AND THE SKIN ERODED OVER THE SCALP AT THE LEAD SITES. THE PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE AND WAS DOING WELL POSTOPERATIVELY. THE DEVICES WERE NOT RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218838 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7071162 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention