BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 4283602 · Received November 24, 2014

    Report

    Report Number
    3005868392-2014-00002
    Event Type
    Injury
    Date Received
    November 24, 2014
    Date of Event
    October 22, 2014
    Report Date
    November 20, 2014
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    OIR
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    FOLLOWING SURGICAL IMPLANTATION OF THE NEURX DIAPHRAGM PACING SYSTEM ON (B)(6) 2014, 2-3 HOURS POST IMPLANT SURGERY THE PATIENT WAS RETURNED TO THE OPERATING ROOM FOR INTERNAL BLEEDING. PER A SURGICAL REPORT OBTAINED FROM THE SITE, THE IMPLANTATION OF THE ELECTRODES WAS UNEVENTFUL. THERE WAS NO BLEEDING. IN THE RECOVERY ROOM, THE PATIENT'S BLOOD PRESSURE WAS ERRATIC, HIS ABDOMEN BECAME SLIGHTLY DISTENDED AND HIS HEMATOCRIT DROPPED. THEY RETURNED TO THE OPERATING ROOM TO EVALUATE PRESUMED BLEEDING AND HEMOPERITONEUM. THE BLOOD IN THE ABDOMEN WAS REMOVED AND IT WAS DISCOVERED HE WAS BLEEDING FROM A ELECTRODE SITE IN THE RIGHT DIAPHRAGM AND ONE ELECTRODE FROM THE LEFT DIAPHRAGM WAS OUT. A SUTURE WAS PLACED IN THE BLEEDING ARTERY AND THE DIAPHRAGM, WHICH STOPPED THE BLEEDING. THE FREE-FLOATING ELECTRODE FROM THE LEFT DIAPHRAGM WAS REMOVED AND A NEW ELECTRODE WAS PLACED. THE BLEEDING WAS STOPPED AND ALL ELECTRODES FUNCTIONED PROPERLY. THE PATIENT WAS STABLE, BLOOD PRESSURE WAS TABLE AND THE PATIENT RETURNED TO THE RECOVERY ROOM IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761323 NEURX DIAPHRAGM PACING SYSTEM OIR SYNAPSE BIOMEDICAL INC. 20-0035 20-0035-082814-2-2

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention