BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 9414067 · Received December 4, 2019

    Report

    Report Number
    3004426659-2019-00061
    Event Type
    Injury
    Date Received
    December 4, 2019
    Date of Event
    November 13, 2019
    Report Date
    December 2, 2019
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    UDI-DI
    00855547005267
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXPLANTED PRODUCT WAS NOT RETURNED TO NEUROPACE FOR ANALYSIS.

    Description of Event or Problem · 1

    ON (B)(6) 2019 THE PATIENT UNDERWENT A ROUTINE RNS NEUROSTIMULATOR REPLACEMENT DUE TO EXPECTED LOW BATTERY. DURING THE FOLLOW-UP APPOINTMENT, THE PATIENT WAS OBSERVED TO HAVE A SCABBED OPENING ABOVE THE CUSTOMIZED CRANIAL IMPLANT (A NON-NEUROPACE PRODUCT), EXPOSING THE CUSTOMIZED CRANIAL IMPLANT AND PROBABLE INFECTION. ON (B)(6) 2019 THE CENTER NOTIFIED NEUROPACE, INC. THAT THE PATIENT HAD AN INFECTION BELOW THE NON-NEUROPACE CRANIAL IMPLANT. ON (B)(6) 2019 THE PATIENT UNDERWENT AN EXPLANT OF THE RNS NEUROSTIMULATOR AND CUSTOMIZED CRANIAL IMPLANT. THE TREATING CENTER DIAGNOSED THE EVENT AS A SUBDURAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1208670 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-320-K 27925-1-1-1 00855547005267

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization