BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 4954174 · Received July 30, 2015

    Report

    Report Number
    3004426659-2015-00016
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    June 23, 2014
    Report Date
    July 17, 2015
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERENCE (B)(4), THIS PATIENT IS PART OF THE CLINICAL TRIAL. (B)(6) 2015 DURING THE ADVERSE EVENT REVIEW FOR THE PAS STUDY IT WAS IDENTIFIED THAT THIS EVENT HAD NOT BEEN REVIEWED ACCORDING TO THE COMPLAINT HANDLING PROCESS. ONCE IDENTIFIED THIS RECORD WAS GENERATED TO MEET THE COMPLAINT REVIEW PROCESS. 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 (B)(6) 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 BASED ON INTERNAL REVIEW OF THE FDA REGULATIONS, GUIDANCE DOCUMENT (DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF), AND INTERNAL PROCEDURES, NEUROPACE, INC.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. PRODUCT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    (B)(6) 2014 - THE SUBJECT UNDERWENT HER THIRD NEUROSTIMULATOR REPLACEMENT PROCEDURE. THE RNS SYSTEM CONFIGURATION FOR THIS SUBJECT INCLUDES A NEUROSTIMULATOR AND TWO CORTICAL STRIP LEADS (CL-315-10). (B)(6) 2014 - INTRAOPERATIVE (ROUTINE RNS REPLACEMENT) SWAB CULTURES OF FERRULE AFTER THE REMOVAL OF THE SUBJECT'S NEUROSTIMULATOR GREW PROPIONIBACTERIUM ACNES AS WELL AS STAPHYLOCOCCUS CAPITIS. THE PATIENT IS ASYMPTOMATIC. PATIENT STATES SHE WAS TOLD SHE WOULD NOT NEED ANY ADDITIONAL TREATMENT AT THIS TIME OTHER THAN THE ROUTINE POST-OP ANTIBIOTICS THAT SHE TOOK. NO INDICATION OF PRODUCT FAILURE. PATIENT WAS TREATED FOR INFECTION WITH ANTIBIOTICS. ANTICIPATED RISK ASSOCIATED WITH CRANIOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497997 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS NEUROSTIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention