BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 12910115 · Received December 1, 2021

    Report

    Report Number
    3004426659-2021-00056
    Event Type
    Injury
    Date Received
    December 1, 2021
    Date of Event
    October 21, 2021
    Report Date
    December 1, 2021
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    UDI-DI
    00855547005366
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE RNS NEUROSTIMULATOR AND NEUROPACE LEADS REMAIN IMPLANTED AND PROGRAMMED FOR USE.

    Description of Event or Problem · 0

    A PATIENT WHO WAS IMPLANTED WITH THE RNS NEUROSTIMULATOR AND TWO DEPTH LEADS ON (B)(6)2021. ON (B)(6) 2021, 80 DAYS AFTER THE MOST RECENT PROCEDURE, THE PATIENT PRESENTED TO AN EMERGENCY DEPARTMENT AND SCALP WOUND CULTURES WERE TAKEN OF THE SCALP WOUND SITE. CULTURES CONFIRMED MRSA, KLEBSIELLA OXYTOCA, RAOUTELLA ORNITHINOLYTICA. ON (B)(6) 2021 THE PATIENT UNDERWENT EXPLORATION OF THE INCISIONS, WOUND WASH OUT, INCISION CLOSURE AND HAD ADDITIONAL CULTURES TAKEN. THE NEUROSTIMULATOR AND LEADS WERE LEFT IN SITU. THE FINAL CULTURE RESULTS INDICATED CORYNEBACTERIUM AND MRSA. TREATMENT INCLUDED DAPTOMYCIN ONCE DAILY FOR 3 WEEKS AND LEVAQUIN PO FOR 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808638 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-320-K 30682-1-1-1 00855547005366

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Other| H