BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 4954085 · Received July 30, 2015

    Report

    Report Number
    3004426659-2015-00008
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    January 20, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON 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. ON 7/1/2015 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 BASED ON INTERNAL REVIEW OF THE FDA REGULATIONS, GUIDANCE DOCUMENT (DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF), AND INTERNAL PROCEDURES, NEUROPACE, INC.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 REMAINS IMPLANTED.

    Description of Event or Problem · 1

    ON 10/01/2014 SUBJECT WAS IMPLANTED WITH THE RNS NEUROSTIMULATOR, TWO DEPTH LEADS (DL-3440-10-K AND DL-330-10-K) AND TWO STRIP LEADS (CL-335-10-K AND CL-325-10-K). 01/20/2015 SITE REPORTED THE SUBJECT HAD A SKIN INFECTION AT THE INCISION SITE. THE SUBJECT WAS PUT ON A PRESCRIPTION FOR KEFLEX. THE SUBJECT'S SYMPTOMS STARTED TO RESOLVE SO THERE WAS NO NEED TO BRING HER IN FOR WOUND DEBRIDEMENT. THE RNS SYSTEM REMAINS IMPLANTED AND IS PROGRAMMED FOR DETECTION AND THERAPY FOR EPILEPSY TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496293 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-300M-K

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention