BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 5266870 · Received December 1, 2015

    Report

    Report Number
    3005868392-2015-00003
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    February 27, 2015
    Report Date
    October 26, 2015
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    OIR
    UDI-DI
    00852184003821
    PMA / PMN Number
    H100006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    PATIENT DEVELOPED TRACK INFECTION AND INFECTION AT SUB-XYPHOID SITE WHERE IMPLANTED OVER AN OLD SCAR. PATIENT ALSO HAD OOZING FROM ELECTRODE BLOCK SITE. IT WAS DECIDED THAT IT WOULD BE BENEFICIAL FOR THE DPS SYSTEM TO BE REMOVED BEFORE SYSTEMIC INFECTION COULD OCCUR. PROBLEMS OBSERVED IN THIS INCIDENT DO NOT APPEAR TO BE RELATED TO ANY DEFECT WITH THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789633 NEURX DIAPHRAGM PACING SYSTEM DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR OIR SYNAPSE BIOMEDICAL INC. 20-0045 20-0045-040414-2-1 00852184003821

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention