BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 7088626 · Received December 6, 2017

    Report

    Report Number
    3004426659-2017-00058
    Event Type
    Injury
    Date Received
    December 6, 2017
    Date of Event
    October 21, 2017
    Report Date
    December 6, 2017
    Manufacturer
    NEUROPACE,INC
    Product Code
    PFN
    UDI-DI
    00855547005120
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL IMPLANT: THE SYSTEM CONSISTS OF THE RNS NEUROSTIMULATOR, PLACED IN THE RIGHT PARIETAL REGION, AND TWO DEPTH LEADS: PORT 1 DL-344, SN (B)(4), LEFT MESIAL TEMPORAL, PORT 2, DL-330, SN (B)(4), RIGHT MESIAL TEMPORAL.

    Description of Event or Problem · 1

    ON (B)(6) 2017 NEUROPACE BECAME AWARE THAT THE PATIENT'S NEUROSTIMULATOR UNDERWENT A DC LEAK RESET ON (B)(6) 2017. THE TREATING SITE WAS CONTACTED IN ORDER TO DETERMINE WHAT HAD OCCURRED. ACCORDING TO THE TREATING SITE, ON (B)(6) 2017 THE PATIENT STATED THEIR INCISION SITE WAS PAINFUL, DRAINING AND RED. THE PATIENT THEN UNDERWENT A WOUND DEBRIDEMENT (RESULTING IN THE NEUROSTIMULATOR DC LEAK) AND WAS ADMINISTERED RIFAMPIN AND DOXYCYCLINE. THE TREATING SITE REPORTED THIS AS A SUPERFICIAL INCISIONAL INFECTION. THE RNS SYSTEM REMAINS IMPLANTED. AT THE TIME OF THE EVENT THE RNS NEUROSTIMULATOR WAS PROGRAMMED FOR DETECTION ONLY, STIMULATION HAD NOT BEEN ENABLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    866513 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE,INC RNS-300M-K 23602-1-1-1 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization| R