BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 4058237 · Received July 3, 2014

    Report

    Report Number
    3005868392-2014-00001
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 31, 2014
    Report Date
    July 2, 2014
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    OIR
    PMA / PMN Number
    H100006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AN EXIT SITE INFECTION WAS REPORTED ABOUT FIVE AN ONE HALF MONTHS AFTER THE SURGERY TO IMPLANT THE DEVICE; THEREFORE, THE INFECTION WAS MOST LIKELY NOT RELATED TO THE SURGERY. SYNAPSE BIOMEDICAL BELIEVES THE INFECTION MOST LIKELY IS RELATED TO INADEQUATE EXIT SITE CLEANING AND CARE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND INSTRUCTIONS FOR EXIT SITE CARE WERE REVIEWED WITH THE CLINICAL STAFF IN THE INSTRUCTIONS FOR USE.

    Description of Event or Problem · 1

    THE CLINICAL SITE TREATING THE PATIENT REPORTED TO THE MANUFACTURER ON (B)(6) 2014 THAT THE PATIENT HAD AN EXIT SITE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392295 NEURX DIAPHRAGM PACING SYSTEM OIR DIAPHRAGMATIC/PHRENIC NERVE LAPARSCOPICALLY-IMPLANTED STIMULATOR OIR SYNAPSE BIOMEDICAL INC. 20-0045 20-0045-100913-10-10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention