BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 4954510 · Received July 30, 2015

    Report

    Report Number
    3004426659-2015-00006
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    April 17, 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
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 5/08/015 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. 6/25/15 NEUROPACE, INC. REOPENED AND 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 BASED ON INTERNAL REVIEW OF THE FDA REGULATIONS, GUIDANCE DOCUMENT (DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF), AND INTERNAL PROCEDURES, NEUROPACE, INC.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) 2014 - THE SUBJECT WAS IMPLANTED WITH A NEUROSTIMULATOR DEVICE AND TWO DEPTH LEADS (DL-330-10-K AND DL-330-3.5-K). (B)(6) 2015 THE FCE (FIELD CLINICAL ENGINEER) SPOKE TO THE NURSE, SHE INDICATED THE SUBJECT REPORTED SOME DRAINAGE OF CLEAR FLUID FROM THE INCISION. SUBSEQUENTLY THE PATIENT WAS EXAMINED BY A PHYSICIAN WHO PRESCRIBED ANTIBIOTICS. (B)(6) 2015: THE SUBJECT UNDERWENT A DEBRIDEMENT PROCEDURE. THE IMPLANTED HARDWARE WAS LEFT IN PLACE. PATHOLOGY DID NOT IDENTIFY AN INFECTIOUS ORGANISM. (B)(6) 2015: THE SUBJECT WAS EXAMINED BY ANOTHER DOCTOR. CLEAR DRAINAGE WAS PRESENT AT THE INCISION LINE. THE DOCTOR COUNSELLED THE SUBJECT AND A DECISION WAS MADE TO REMOVE THE IMPLANTED HARDWARE AND PLAN FOR A POTENTIAL RE-IMPLANTATION IN SEVERAL MONTHS. (B)(6) 2015: THE IMPLANTED HARDWARE WAS REMOVED. PATHOLOGY RESULTS DID NOT IDENTIFY AN INFECTIOUS ORGANISM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497040 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS NEUROSTIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention