BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 6557266 · Received May 10, 2017

    Report

    Report Number
    3004426659-2017-00019
    Event Type
    Injury
    Date Received
    May 10, 2017
    Date of Event
    April 14, 2017
    Report Date
    May 10, 2017
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    UDI-DI
    00855547005120
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - PATIENT'S FIRST IMPLANT, RNS SYSTEM INCLUDED RNS AND PORT 1: DL-330, SN (B)(4), RIGHT MESIAL TEMPORAL. PORT 2: CL-325, SN (B)(4), RIGHT TEMPORAL, NON-MESIAL. DEPTH LEAD WAS SECURED WITH BURR HOLE COVER.

    Description of Event or Problem · 1

    PATIENT UNDERWENT WOUND REVISION WHEN IT WAS IDENTIFIED THAT THE INCISION SITE WAS NOT HEALING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340088 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-300M-K 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R