BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 4954063 · Received July 30, 2015

    Report

    Report Number
    3004426659-2015-00004
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    April 4, 2015
    Report Date
    July 27, 2015
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 5/07/2015 NEUROPACE, INC. VOIDED THIS COMPLAINT. THERE WAS NO REPORTED PRODUCT MALFUNCTION AND NO INDICATION THE PRODUCT CONTRIBUTED TO THE INFECTION. INFECTIONS ARE ANTICIPATED WHEN PERFORMING CRANIOTOMY PROCEDURES. 6/25/2015 NEUROPACE, INC. REEVALUATED THIS RECORD. BASED ON INTERNAL REVIEW OF THE FDA REGULATIONS, GUIDANCE DOCUMENT (DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF), AND INTERNAL PROCEDURES, NEUROPACE, INC. DETERMINED THAT COMPLAINTS ASSOCIATED WITH INCISION SITE INFECTIONS ARE REPORTABLE. THESE PAST EVENTS SHOW NO INDICATION THAT THE PRODUCT CAUSED THE INFECTION AND THERE IS NO INDICATION OF PRODUCT FAILURE. STERILITY RECORD REVIEW PERFORMED. NO EVIDENCE OF FACTORS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. ALL STERILIZATION RESULTS MET REQUIREMENTS AS SPECIFIED IN THE SPECIFICATIONS. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    (B)(6) 2015 THE SUBJECT WAS IMPLANTED WITH RNS NEUROSTIMULATOR AND THREE CORTICAL STRIP LEADS (CL-325-10-K). (B)(6) 2015 THE FCE WAS NOTIFIED THAT THE RNS SYSTEM (DEVICE AND LEADS) HAD BEEN EXPLANTED SECONDARY TO THE SUBJECT BEING "SEPTIC". INFECTION WAS AT IMPLANT SITE. SUBJECT IS ON ANTIBIOTIC TREATMENT AND IS REPORTED TO BE DOING WELL. CULTURE WAS POSITIVE FOR (B)(6). NO WOUND DEHISCENCE WAS OBSERVED. DETAILS: (B)(6); DISCHARGED HOME FROM INITIAL IMPLANT SURGERY ON CEFDINIR. THEN PUT ON OXACILLIN 2 GRAMS EVERY 4 HOURS VIA PICC LINE. (B)(6) 2015 THE SUBJECT WAS REPORTED "AS DOING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496288 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS NEUROSTIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R