BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RNS SYSTEM

    MDR report key: 3923872 · Received July 9, 2014

    Report

    Report Number
    3004426659-2014-00004
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    June 19, 2014
    Report Date
    July 9, 2014
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION OF THE RETURNED EXPLANTED LEADS AND NEUROSTIMULATOR WAS PERFORMED. THERE WAS NO EVIDENCE OF NEUROSTIMULATOR NOR LEAD FAILURE. PERFORMED REVIEW OF STERILITY TEST REPORTS AND BATCH RECORDS. ALL TESTS AND REPORTS PASSED. NO EVIDENCE OF FACTORS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT (INFECTION).

    Description of Event or Problem · 1

    THE PATIENT HAS BEEN RETURNING TO THE CLINIC POST SURGERY TO HAVE HIS INCISION CHECKED. THE INCISION HAS NOT HEALED WELL WITH SIGNS OF INFECTION. THE NEUROSURGEON ELECTED TO EXPLANT THE ENTIRE SYSTEM. COMPLETE SYSTEM EXPLANT DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401693 RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-300M-K

    Patients

    Seq Age Sex Outcome Treatment
    1 25 Required Intervention