BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 17238585 · Received June 30, 2023

    Report

    Report Number
    3006630150-2023-03783
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    August 1, 2021
    Report Date
    August 4, 2023
    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
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO FIELD BSC AWARE DATE. THE CORRECT AWARE DATE IS 13DEC2021 NOT 17AUG2021 AS INITIALLY REPORTED.

    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)(6); BATCH: 7072901. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); BATCH: 7073571. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); BATCH: 7073485.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS AND LEAD EXTENSIONS WERE EXPLANTED. THE EXPLANTED DEVICES WERE DISPOSED OF AT THE HOSPITAL AND WERE NOT RETURNED TO BSC.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEADS AND LEAD EXTENSIONS WERE EXPLANTED. THE EXPLANTED DEVICES WERE DISPOSED OF AT THE HOSPITAL AND WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265299 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7072886 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention