BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 6996138 · Received November 2, 2017

    Report

    Report Number
    3004426659-2017-00049
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    September 15, 2017
    Report Date
    October 31, 2017
    Manufacturer
    NEUROPACE,INC
    Product Code
    PFN
    UDI-DI
    00855547005120
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS THE PATIENT'S 5TH NEUROSTIMULATOR. THE PATIENT'S SYSTEM CONSISTED OF THE RNS NEUROSTIMULATOR AND TWO LEADS: PORT 1, CL- SN (B)(4), LEFT TEMPORAL SUBDURAL AND PORT 2, DL -SN (B)(4), LEFT MESIAL TEMPORAL.

    Description of Event or Problem · 1

    THE PATIENT'S RNS NEUROSTIMULATOR AND LEADS WERE EXPLANTED IN RESPONSE TO AN IMPLANT SITE INFECTION. THE DETAILS OF THE INFECTION NOR THE PROCEDURE HAVE NOT BEEN PROVIDED BY THE TREATING CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777673 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE,INC RNS-300M-K 22812-1-1-1 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R