BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 7791583 · Received August 16, 2018

    Report

    Report Number
    3004426659-2018-00037
    Event Type
    Injury
    Date Received
    August 16, 2018
    Date of Event
    December 12, 2017
    Report Date
    August 15, 2018
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    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

    ON (B)(6) 2017 A SIGNAL ARTIFACT WAS OBSERVED ON THE LEFT DEPTH LEAD INDICATING A POTENTIAL LEAD BREAK. ON (B)(6) 2017 A LEAD REVISION WAS PERFORMED AND THE DEPTH LEAD WITH THE SIGNAL ARTIFACT WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED. THE EXPLANTED LEAD WAS NOT RETURNED TO NEUROPACE FOR INVESTIGATION. THE PATIENT DOES OCCASIONALLY FALL DURING SEIZURES BUT THE TREATING CENTER WAS UNABLE TO DETERMINE IF THIS WAS THE CAUSE OF THE POSSIBLE BREAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630866 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. DL-344-10-K 18860-1-1-1

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Hospitalization