BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 7807981 · Received August 22, 2018

    Report

    Report Number
    3004426659-2018-00028
    Event Type
    Injury
    Date Received
    August 22, 2018
    Date of Event
    May 28, 2018
    Report Date
    August 20, 2018
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    UDI-DI
    00855547005014
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED LEAD WAS NOT RETURNED TO NEUROPACE FOR ANALYSIS, HOWEVER REVIEW OF THE LEAD IMPEDANCE AND ECOG DATA WAS PERFORMED AND THE DATA IS CONSISTENT WITH A LEAD BREAK.

    Description of Event or Problem · 1

    ON (B)(6) 2018, THE TREATING CENTER CONTACTED NEUROPACE FIELD SUPPORT PERSONNEL AFTER NOTING ARTIFACT ON THE ECOG SIGNAL FROM THE PATIENT'S RIGHT DEPTH LEAD. AFTER REVIEW BY NEUROPACE, INC., IT WAS DETERMINED THE SIGNAL ARTIFACT NOTED WAS CONSISTENT WITH THOSE SEEN WITH A POTENTIAL LEAD BREAK. THE LEAD BREAK WAS ATTRIBUTED BY THE TREATING CENTER , AS A LEAD ROUTING ISSUE, AS THE LEAD HAD ENDED UP FOLDING OVER ON ITSELF.THE LEAD WAS EXPLANTED ON (B)(6) 2018 AND A NEW LEAD WAS PLACED ON (B)(6) 2018. THE LEAD WAS DISCARDED AT THE TREATING CENTER PER THE NEUROSURGEON'S INSTRUCTIONS; AND THEREFORE WAS NOT RETURNED TO NEUROPACE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645157 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. DL-344-10-K 24132-1-1-1 00855547005014

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Hospitalization