BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 8064549 · Received November 13, 2018

    Report

    Report Number
    3004426659-2018-00046
    Event Type
    Injury
    Date Received
    November 13, 2018
    Date of Event
    October 4, 2018
    Report Date
    November 12, 2018
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    UDI-DI
    00855547005045
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ECOG AND IMPEDANCE DATA ARE SUGGESTIVE OF A POTENTIAL LEAD BREAK. NEUROPACE WAS UNABLE TO DETERMINE A ROOT CAUSE. THE EXPLANTED PRODUCT WAS NOT RETURNED TO NEUROPACE, INC.

    Description of Event or Problem · 1

    BASED ON THE REVIEW OF THE PATIENT'S ECOGS BY THE TREATING CENTER, A SIGNAL ARTIFACT WAS IDENTIFIED ON THE RIGHT DEPTH LEAD INDICATING A POTENTIAL LEAD BREAK. PER THE TREATING CENTER, THE PATIENT FELL DUE TO A SEIZURE IN MAY 2018 AND HIT HER HEAD WHICH IS FELT TO BE THE PROBABLE CAUSE OF THE POSSIBLE LEAD BREAK. THE PATIENT DOES NOT FREQUENTLY INTERROGATE AND SYNCHRONIZE HER NEUROSTIMULATOR AND THEREFORE THIS ISSUE WAS NOT IDENTIFIED UNTIL (B)(6) 2018. DURING A ROUTINE NEUROSTIMULATOR REPLACEMENT ON (B)(6) 2018, THE LEAD WITH THE SIGNAL ARTIFACT WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED AND CONNECTED TO THE RNS NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907331 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. DL-330-10-K 19506-1-1-1 00855547005045

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization