BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 4203732 · Received October 27, 2014

    Report

    Report Number
    3004426659-2014-00013
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    June 10, 2014
    Report Date
    October 20, 2014
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT TO BE RETURNED.

    Description of Event or Problem · 1

    (B)(6) 2014 PATIENT UNDERWENT NEUROSTIMULATOR REPLACEMENT DUE TO NEUROSTIMULATOR BATTERY REACHING ELECTIVE REPLACEMENT PERIOD. THIS IS HER FIFTH DEVICE. PATIENT IS IMPLANTED WITH FOUR CORTICAL STRIP LEADS. THE PATIENT PRESENTED WITH DRAINAGE AT THE NEUROSTIMULATOR INCISION SITE. APPEARS TO BE A SOFT TISSUE INFECTION. NO FEVER, VOMITING OR NAUSEA WAS REPORTED. NO INDICATIONS OF DEVICE MALFUNCTION AT EXPLANT. (B)(6) 2014 DR. (B)(6) CONTACTED THE FCE (FIELD CLINICAL ENGINEER) REQUESTING EXPERIENCED RECOMMENDATIONS REGARDING TREATMENT. (B)(6) 2014 (B)(6) SENT EMAIL TO THE FCE INDICATING THAT HE WAS IN THE PROCESS OR REMOVING ENTIRE RNS SYSTEM AFTER DISCUSSION WITH PATIENT AND FAMILY. SURGEON INDICATED PATIENT WILL NOT BE A CANDIDATE FOR REIMPLANTATION OF RNS SYSTEM AS PATIENT DID NOT RECEIVE DESIRED EFFICACY. THERE IS NO INDICATION OF PRODUCT MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682759 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-300M-K

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Hospitalization