BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 15503561 · Received September 29, 2022

    Report

    Report Number
    3006630150-2022-05093
    Event Type
    Injury
    Date Received
    September 29, 2022
    Date of Event
    September 6, 2022
    Report Date
    September 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(4); LOT: 7100652. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(4); LOT: 7100983. PRODUCT FAMILY: DBS-LEAD FIXATION; UPN: M365DB4600C0; MODEL: DB-4600C; SERIAL: N/A; LOT: 26612852. PRODUCT FAMILY: DBS-IPG-R-MRI; UPN: M365DB12160; MODEL: DB-1216; SERIAL: (B)(4); LOT: 538941.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A NON-DEVICE RELATED INFECTION IN THE HEAD. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE DEEP BRAIN STIMULATION DEVICES WERE REMOVED AND THE INFECTED SITE WAS WASHED. THE PATIENT WAS RECOVERING AT HOME. IT IS UNKNOWN IF CULTURES WERE TAKEN, WHAT THE SYMPTOMS OF THE INFECTION WERE OR IF ANTIBIOTICS WERE ADMINISTERED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766808 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7092591 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention