BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 7610925 · Received June 18, 2018

    Report

    Report Number
    3005868392-2018-00002
    Event Type
    Injury
    Date Received
    June 18, 2018
    Date of Event
    May 14, 2018
    Report Date
    June 18, 2018
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    OIR
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH THE NEURX DPS DEVICE ON (B)(6) 2018. THE PATIENT REMAINED IN THE HOSPITAL WHILE RECOVERING FROM CONCOMITANT PHRENIC NERVE GRAFT SURGERY AND WAITING FOR PLACEMENT IN A NURSING FACILITY. IT IS POLICY AT THE HOSPITAL THAT VENTILATOR DEPENDENT PATIENTS ARE ON CONTINUOUS CARDIAC AND PULSE/OX MONITORING. ON (B)(6) 2018 THE PATIENT EXPERIENCED VENTRICULAR FIBRILLATION FOR ABOUT 40 SECONDS. THE FIBRILLATION RESOLVED ON ITS OWN WITHOUT INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451738 NEURX DIAPHRAGM PACING SYSTEM NEURX DIAPHRAGM PACING SYSTEM OIR SYNAPSE BIOMEDICAL INC. 20-0035 20-0035-040418-2-1

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Life Threatening| R