BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 6763312 · Received August 3, 2017

    Report

    Report Number
    3004426659-2017-00034
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    July 6, 2017
    Report Date
    August 3, 2017
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    UDI-DI
    00855547005120
    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). PATIENT WAS IMPLANTED WITH THE RNS NEUROSTIMULATOR AND TWO DEPTH LEADS. PORT 1, DL-330-10, SN (B)(4), LEFT MESIAL TEMPORAL. PORT 2, DL-330-10, SN (B)(4), RIGHT MESIAL TEMPORAL.

    Description of Event or Problem · 1

    THE PATIENT WAS NOTED TO HAVE LEFT SIDED WEAKNESS ON EXAM THE MORNING FOLLOWING RNS SYSTEM IMPLANTATION (INITIALLY POST-OP, SHE WAS FULL STRENGTH) WHICH PROMPTED A CT SCAN. THE PATIENT WAS FOUND TO HAVE AN EPIDURAL HEMATOMA AT THE RNS NEUROSTIMULATOR SITE UNDERLYING THE CRANIOTOMY AND EXTENDING ANTEROLATERALLY. THE PATIENT WAS TAKEN BACK TO THE OR FOR CLOT EVACUATION. THE RNS NEUROSTIMULATOR WAS TEMPORARILY REMOVED (THOUGH NOT DISCONNECTED), THE CLOT WAS EVACUATED, AND DURAL TENTING SUTURES WERE PLACED. HOWEVER, BLOOD DISSECTED INTO THE EPIDURAL SPACE LATERAL TO THE ORIGINAL CRANIOTOMY REACCUMULATED, AND SO THE PATIENT WAS TAKEN BACK TO THE OR FOR A SEPARATE CRANIOTOMY FOR EPIDURAL HEMORRHAGE EVACUATION. POST-EVACUATION, THE PATIENT CONTINUED TO EXPERIENCE SOME MILD WEAKNESS. NO PRODUCT WAS EXPLANTED THROUGHOUT THE SURGICAL INTERVENTIONS. THE RNS SYSTEM REMAINS IMPLANTED AND IS PROGRAMMED FOR DETECTION AND THERAPY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546306 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-300M-K 23328-1-1-1 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R