BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 16877104 · Received May 5, 2023

    Report

    Report Number
    3006630150-2023-02521
    Event Type
    Injury
    Date Received
    May 5, 2023
    Date of Event
    April 1, 2023
    Report Date
    May 5, 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
    LA, 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)(6), BATCH: 7101578. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5000287. PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5000502.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A SUSPECTED INFECTION LOCATED NEAR THE SITE OF THE LEAD AND LEAD EXTENSION. THE PATIENT UNDERWENT A PROCEDURE WHERE THE AREA OF THE SUSPECTED INFECTION WAS WASHED OUT. THE PROCEDURE SHOWED THAT NONE OF THE DBS COMPONENTS WERE INFECTED OR NEEDED TO BE EXPLANTED. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND WAS DOING WELL POST-OPERATIVELY. A CULTURE WAS TAKEN AND REVEALED NO DEFINITIVE ORGANISMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670635 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7101572 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention