BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 4797745 · Received May 26, 2015

    Report

    Report Number
    3005868392-2015-00001
    Event Type
    Injury
    Date Received
    May 26, 2015
    Date of Event
    February 4, 2015
    Report Date
    May 20, 2015
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    OIR
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOLLOWING A SURGICAL PROCEDURE TO REPLACE THE PERCUTANEOUS ELECTRODES OF THE NEURX DIAPHRAGM PACING SYSTEM, THE SURGICAL SITE OF THE REPLACEMENT ELECTRODES HAD NOT HEALED APPROPRIATELY AND THE ELECTRODES ERODED THROUGH THE SKIN. THE PT AND SURGEON OPTED TO RETURN TO SURGERY TO CLEAN AND REPAIR THE SURGICAL SITE AND REPLACE THE ELECTRODES AGAIN. THE SURGERY WAS SUCCESSFUL AND THE PT WAS ABLE TO USE THE DPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340790 NEURX DIAPHRAGM PACING SYSTEM OIR SYNAPSE BIOMEDICAL INC. 20-0035 20-0035-100609-2-2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention