BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEURX DIAGPHRAGM PACING SYSTEM

    MDR report key: 5266874 · Received December 1, 2015

    Report

    Report Number
    3005868392-2015-00002
    Event Type
    Injury
    Date Received
    December 1, 2015
    Date of Event
    March 18, 2015
    Report Date
    October 26, 2015
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    OIR
    UDI-DI
    00852184003281
    PMA / PMN Number
    H100006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    1

    Narratives

    Description of Event or Problem · 1

    INFECTION IN ONE OF THE ELECTRODE LEAD TRACKS. THE PATIENT AND SURGEON OPTED TO CUT AFFECTED WIRE AND ADDED A WOUND VAC TO CLEAR UP DRAINAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790279 NEURX DIAGPHRAGM PACING SYSTEM DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR OIR SYNAPSE BIOMEDICAL INC. 20-0045 20-0045-100212-10-1 00852184003281

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention