BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROPACE RNS SYSTEM

    MDR report key: 6803728 · Received August 18, 2017

    Report

    Report Number
    3004426659-2017-00035
    Event Type
    Injury
    Date Received
    August 18, 2017
    Date of Event
    July 5, 2017
    Report Date
    August 16, 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). INITIAL IMPLANT, RNS AND TWO DEPTH LEADS. PORT 1, DL-344-10, SN (B)(4), LEFT MESIAL TEMPORAL. PORT 2. DL-330-10, SN (B)(4), RIGHT MESIAL TEMPORAL.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH THE RNS SYSTEM ON (B)(6) 2017 WITH NO INTRAOPERATIVE COMPLICATIONS. A ROUTINE POST-OP SCAN WAS PERFORMED WHICH DID NOT DEMONSTRATE ANY HEMORRHAGE OR ACUTE CHANGES. ON (B)(6) 2017, THE PATIENT NOTICED AN ACUTE CHANGE IN VISION LOSS. A CT SCAN OF THE HEAD WAS OBTAINED SHOWING A NEW RIGHT OCCIPITAL INTRACEREBRAL HEMORRHAGE ALONG THE TRACT OF THE RIGHT DEPTH ELECTRODE. PATIENT WAS NEUROLOGICALLY INTACT EXCEPT FOR CONFUSION AND A NEW LEFT-SIDED FIELD CUT IN BILATERAL EYES. PATIENT WAS MOVED TO THE NEUROLOGICAL ICU AND HAD SERIAL CT HEAD SCANS PERFORMED WHICH DID NOT SHOW ANY EVOLUTION OF THE HEMORRHAGE. OF NOTE, THE PATIENT DID NOT RECEIVE HER DVT (DEEP VEIN THROMBOSIS) PROPHYLAXIS BEFORE THE SPONTANEOUS HEMORRHAGE. PATIENT WAS SEEN BY PT (PHYSICAL THERAPY) AND OT (OCCUPATIONAL THERAPY) DURING THE HOSPITALIZATION; HOWEVER NO SURGICAL INTERVENTION WAS PERFORMED FOR THE HEMORRHAGE. PATIENT WAS DISCHARGED ON 7/10/2017, AS THE PATIENT WAS STILL SYMPTOMATIC (DISORIENTATION, IMBALANCE AND LEFT EYE VISION LOSS) SHE WAS ADMITTED TO AN INPATIENT REHAB FACILITY ON THE 19TH. PER PATENT'S HUSBAND, THE PATIENT IS DOING BETTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584559 NEUROPACE RNS SYSTEM NEUROPACE RNS SYSTEM PFN NEUROPACE, INC. 1007603 00855547005120

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R