BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 4954086 · Received July 30, 2015

    Report

    Report Number
    3004426659-2015-00009
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    November 20, 2014
    Report Date
    July 28, 2015
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    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 EVENT. THE RISK OF THE NOTED CONDITION HAD BEEN PREVIOUSLY ASSESSED AND MITIGATED, AND THE ROUTINE ACTIONS TAKEN WERE CONSISTENT WITH STANDARD PATIENT CARE, PROVIDING EFFECTIVE TREATMENT FOR THE SUBJECT. 7/7/2015 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 BASED ON INTERNAL REVIEW OF THE FDA REGULATIONS, GUIDANCE DOCUMENT (DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF), AND INTERNAL PROCEDURES, NEUROPACE, INC.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 WOUND HEALING MAY BE REPORTABLE. THESE PAST EVENTS SHOW NO INDICATION THAT THE PRODUCT CAUSED THE WOUND NOT TO HEAL AND THERE IS NO INDICATION OF PRODUCT FAILURE. THE RNS SYSTEM REMAINS IMPLANTED AND IS PROGRAMMED FOR DETECTION AND THERAPY FOR EPILEPSY TREATMENT. DEVICE REMAINS IMPLANTED

    Description of Event or Problem · 1

    (B)(6) 2014 - THE SUBJECT WAS IMPLANTED WITH THE RNS NEUROSTIMULATOR AND (4) CORTICAL LEADS. CONNECTED TO THE DEVICE, CL-325-10-K AND CL-315-10-K. NOT CONNECTED TO THE DEVICE BUT ALSO IMPLANTED, CL-325-10-K AND CL-325-10-K (B)(6) 2014 - THE SUBJECT'S HUSBAND REPORTED THAT THE INCISION WAS OPEN AT THE SITE OF THE IMPLANT. THE SUBJECT RETURNED TO HAVE THE INCISION RECLOSED. (B)(6) 2014 - THE SUBJECT RETURNED TO THE NEUROLOGIST FOR FOLLOW-UP. THE SURGEON WAS HAPPY WITH HOW THE INCISION WAS CLOSING. (B)(6) 2015 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
    496505 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS NEUROSTIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention