BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 5540962 · Received April 1, 2016

    Report

    Report Number
    3004426659-2016-00008
    Event Type
    Injury
    Date Received
    April 1, 2016
    Date of Event
    March 11, 2016
    Report Date
    March 31, 2016
    Manufacturer
    NEUROPACE, INC.
    Product Code
    PFN
    PMA / PMN Number
    P100026
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTED RNS SYSTEM CONSISTS OF THE FOLLOWING RNS-300, SN (B)(4), IMPLANTED (B)(6) 2013. CL-325-10K, SN (B)(4), 101292 IMPLANTED (B)(6) 2005. DL-344-10-K, SN (B)(4), IMPLANTED (B)(6) 2005. CL-325-10, SN (B)(4), IMPLANTED (B)(6) 2005.

    Description of Event or Problem · 1

    THE RNS SYSTEM INCLUDING THE NEUROSTIMULATOR, FERRULE AND LEADS WERE ALL EXPLANTED ON (B)(6) 2016 AFTER PATIENT'S INCISION FAILED TO HEAL PROPERLY AFTER AN ATTEMPT AT A WOUND REVISION. THE INCISION CONTINUED TO SHOW SIGNS OF WOUND DEHISCENCE AND THEREFORE THE DECISION WAS MADE TO REMOVE ALL PRODUCT. UPON REMOVAL OF THE LEADS, THE SURGEON NOTED THAT A PORTION OF THE INSULATION ON ONE OF THE LEADS WAS NOT PRESENT. IT WAS NOT CLEAR WHAT LEAD THIS WAS AS THE SURGEON OPTED NOT TO OPEN THE CRANIOTOMY TO REMOVE THE ELECTRODE PORTION OF THE LEADS AND WILL DO SO WHEN THE PATIENT IS RE-IMPLANTED AT A LATER DATE. ALL PRODUCT HAS BEEN RETURNED TO NEUROPACE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196254 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. 1007283

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R