BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 14837080 · Received June 27, 2022

    Report

    Report Number
    3006630150-2022-03131
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    June 2, 2021
    Report Date
    June 27, 2022
    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
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT DATE: EXACT DATE UNKNOWN, EVENT OCCURRED PRIOR TO EXPLANT ON (B)(6) 2021. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(4); BATCH: 7077509. PRODUCT FAMILY: DBS-IPG-R-MRI; UPN: M365DB1200S0; MODEL: DB-1200-S; SERIAL: (B)(4); BATCH: 744531. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(4); BATCH: 7078168. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(4); BATCH: 7080604.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED EROSION ON THE LEFT SCALP BETWEEN THE EXTENSION AND THE ELECTRODE, PROXIMAL TO THE EXTENSION INCISION OVER INTACT SKIN. CULTURES TAKEN TESTED POSITIVE FOR TWO STRAINS OF METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA). THE PHYSICIAN ASSESSED THAT THE PATIENT HAD AN INCREASED RISK OF INFECTION DUE TO BEING ON PRADAXA FOR LUPUS ANTICOAGULATION AND HISTORY OF DEEP VEIN THROMBOSIS (DVT)/PULMONARY EMBOLISM (PE). THE PATIENT UNDERWENT A PROCEDURE WHERE THE DEEP BRAIN STIMULATION SYSTEM WAS REMOVED. THE DEVICES WERE DISCARDED BY THE FACILITY AND WERE NOT RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017536 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7077635 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention