BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 7009793 · Received November 8, 2017

    Report

    Report Number
    3004426659-2017-00052
    Event Type
    Injury
    Date Received
    November 8, 2017
    Date of Event
    October 9, 2017
    Report Date
    November 7, 2017
    Manufacturer
    NEUROPACE,INC
    Product Code
    PFN
    UDI-DI
    00855547005120
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE RETURNED RNS NEUROSTIMULATOR AND TWO DEPTH LEADS WERE INVESTIGATED. THERE IS NO INDICATION OF PRODUCT MALFUNCTION. THERE WAS NO EVIDENCE OF FACTORS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE SYSTEM INCLUDED THE RNS NEUROSTIMULATOR AND TWO DEPTH LEADS: PORT 1, DL-344, SN (B)(4), RIGHT FRONTAL AND PORT 2 , DL-344, SN (B)(4), RIGHT FRONTAL POSTERIOR.

    Description of Event or Problem · 1

    NEUROPACE WAS INFORMED ON (B)(6) 2017 THAT THE PATIENT'S NEUROSTIMULATOR AND TWO DEPTH LEADS WERE EXPLANTED . WHEN THE PATIENT'S HEAD WAS SHAVED, A SMALL PORTION OF BOTH LEADS WERE EXPOSED AT THE INCISION SITE. NO FURTHER DETAILS REGARDING THE EVENT WERE PROVIDED BY THE TREATMENT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790696 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE,INC RNS-300M-K 22391-1-1-1 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R