BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 7193748 · Received January 16, 2018

    Report

    Report Number
    3004426659-2017-00063
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    December 22, 2017
    Report Date
    January 15, 2018
    Manufacturer
    NEUROPACE,INC
    Product Code
    PFN
    UDI-DI
    00855547005120
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL IMPLANT, SYSTEM INCLUDED RNS NEUROSTIMULATOR AND FOUR DEPTH LEADS : PORT 1 DL-330 LEFT OCCIPITAL, PORT 2, DL-344, RIGHT OCCIPITAL, NOT CONNECTED DL-330 , RIGHT OCCIPITAL AND NOT CONNECTED DL-330, LEFT OCCIPITAL.

    Description of Event or Problem · 1

    ON (B)(6) 2017, THE TREATING CENTER REPORTED THAT THE PATIENT HAD DEVELOPED PURULENT DRAINAGE FROM A SMALL PINHOLE SIZE OPENING AT THE INCISION SITE. ON (B)(6) 2017, THE PATIENT'S WAS TAKEN TO THE OR FOR EVALUATION AND THE INCISION SITE WAS OPENED, EXPLORED AND IMMEDIATELY CLOSED. NO PURULENCE WAS IDENTIFIED, NO INFECTION APPEARED TO BE PRESENT, AND NO CULTURE WAS TAKEN. THE PATIENT WAS STARTED ON ANTIBIOTICS AND NO ADDITIONAL DRAINAGE WAS SEEN. ALL RNS SYSTEM PRODUCT REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39481 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE,INC RNS-300M-K 22950-1-1-1 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R