BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 6996137 · Received November 2, 2017

    Report

    Report Number
    3004426659-2017-00051
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 30, 2017
    Manufacturer
    NEUROPACE,INC
    Product Code
    PFN
    UDI-DI
    00855547005120
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SYSTEM INCLUDED RNS NEUROSTIMULATOR AND TWO DEPTH LEADS: PORT 1 DL-330, SN 190614, LEFT MESIAL TEMPORAL HIPPOCAMPUS AND PORT 2, DL-344, SN (B)(4) , RIGHT MESIAL TEMPORAL HIPPOCAMPUS

    Description of Event or Problem · 1

    THE PATIENT WAS ADMITTED ON (B)(6) 2017 FOR TREATMENT OF LEFT SCALP WOUND DEHISCENCE WHICH HAD SUBSEQUENTLY BECOME INFECTED. THE RNS NEUROSTIMULATOR AND LEADS WERE EXPLANTED ON (B)(6) 2017 AND THE PATIENT WAS PLACED ON ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777672 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE,INC RNS-300M-K 20798-1-1-1 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R