BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 7292780 · Received February 23, 2018

    Report

    Report Number
    3004426659-2018-00007
    Event Type
    Injury
    Date Received
    February 23, 2018
    Date of Event
    January 24, 2018
    Report Date
    February 23, 2018
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    UDI-DI
    00855547005120
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL SYSTEM IMPLANT INCLUDES RNS NEUROSTIMULATOR AND TWO DEPTH LEADS. PORT 1, DL-344-10, LEFT MESIAL TEMPORAL. PORT 2, DL-330-10, RIGHT MESIAL TEMPORAL, BURR HOLE COVER.

    Description of Event or Problem · 1

    ON (B)(6) 2018 THE TREATING CENTER OBSERVED PUS DRAINING FROM THE INCISION SITE. THE PATIENT WAS TAKEN TO OR THAT EVENING FOR IRRIGATION, DEBRIDEMENT AND REMOVAL OF THE RNS NEUROSTIMULATOR AND BOTH LEADS. THE PATIENT WAS PLACED ON A 6 WEEK COURSE OF IV ANTIBIOTICS AS PER INFECTIOUS DISEASE. THE TREATING CENTER CATEGORIZED THE INFECTION AS A SUPERFICIAL AND DEEP INCISIONAL INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135468 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-300M-K 23821-1-1-1 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization| R