BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 6200042 · Received December 22, 2016

    Report

    Report Number
    3004426659-2016-00032
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 16, 2016
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    UDI-DI
    00855547005120
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2016 PATIENT WAS IMPLANTED WITH RNS SYSTEM INCLUDING NEUROSTIMULATOR AND TWO DEPTH LEADS (DL-344-10-K). AS OF (B)(6) 2016 DETECTING WAS ON, TREATMENT IS OFF. ON (B)(6) 2016 THE PATIENT WAS ADMITTED TO (B)(6) AND THE DEVICE WAS REMOVED. SUSPECTED INFECTION FROM EROSION. PATIENT WILL BE ON IV ANTIBIOTICS FOR 6 WEEKS. ACCORDING TO THE PHYSICIAN THIS PATIENT BUMPED HIS HEAD A WHILE BACK AND PICKED AWAY AT THE ABRASION UNTIL THE DEVICE BECAME EXPOSED. PATIENT WILL BE IN IV ANTIBIOTICS FOR THE NEXT 6 WEEKS. ADDITIONAL DETAILS ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849915 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-300M-K - FGI, NS, RNS-300M-K 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R