BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RNS SYSTEM

    MDR report key: 3839501 · Received May 29, 2014

    Report

    Report Number
    3004426659-2014-00003
    Event Type
    Injury
    Date Received
    May 29, 2014
    Date of Event
    May 22, 2014
    Report Date
    May 23, 2014
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO NEUROPACE FOR INVESTIGATION AND DECONTAMINATION. THE DEVICE WA SUCCESSFULLY INTERROGATED AND THE DATA SYNCHRONIZED. THE PRODUCT PERFORMED AS EXPECTED. NO FAULT FOUND.

    Description of Event or Problem · 1

    PATIENT REPORTED WOUND HEALING ISSUES APPROXIMATELY A MONTH AFTER REPLACEMENT IMPLANT. NEUROSURGEON REMOVED NEUROSTIMULATOR AND FERRULE. STRIPS REMAIN IMPLANTED. (B)(6) 2014 PATIENT NOTIFIED SITE THAT SHE WAS HAVING WOUND HEALING ISSUES. SITE INSTRUCTED PATIENT TO SEE LOCAL MD. (B)(6) 2014 NP WAS CONTACTED BY SITE STATING PATIENT WAS GOING TO BE SEEN BY NS FOR WOUND ISSUE. AWARE DATE (B)(6) 2014 PATIENT WAS SEEN BY SITE (NS) AND DECISION WAS MADE TO EXPLANT RNS. (B)(6) 2014 PATIENT TAKEN TO SURGERY; RNS AND FERRULE EXPLANTED; CULTURES TAKEN AND SENT TO PATHOLOGY. LEADS REMAIN IN PLACE AND WERE CAPPED; SUTURES PLACED FOR IDENTIFICATION PURPOSES. (B)(6) 2014 THE FCE REPORTED THAT THE PATIENT HAD EROSION AT THE WOUND SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316445 RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. RNS-300M

    Patients

    Seq Age Sex Outcome Treatment
    1 27 Required Intervention