BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 5628922 · Received May 3, 2016

    Report

    Report Number
    3005868392-2016-00001
    Event Type
    Death
    Date Received
    May 3, 2016
    Report Date
    March 2, 2016
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    OIR
    UDI-DI
    00852184003281
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS EVENT WAS SENT DIRECTLY FROM THE USER FACILITY TO A CERTIFIED, INDEPENDENT LABORATORY ((B)(6)) FOR TESTING. THE TESTING WAS PERFORMED IN ACCORDANCE WITH A PROTOCOL PROVIDED BY SYNAPSE BIOMEDICAL INC. THE PROTOCOL AND SUMMARY OF THE RESULTS OBTAINED ARE PROVIDED. THE FINAL REPORT HAS NOT BEEN COMPLETED BUT WILL BE SUBMITTED IN A FOLLOW-UP REPORT, WHICH WILL CONTAIN DETAILS FOR EACH TEST CONDUCTED. SYNAPSE BIOMEDICAL INC. HAS NO FURTHER DETAILS REGARDING THE ADVERSE EVENT OTHER THAN THOSE PRESENTED IN THE USER FACILITY REPORT. WE HAVE HAD NO CONTACT WITH THE PATIENT'S FAMILY OR ANYONE ELSE DIRECTLY INVOLVED AND IT SHOULD BE NOTED THAT THE PATIENT WAS NOT AT THE USER FACILITY AT THE TIME OF THE INCIDENT. THE ONLY MECHANISM FOR DEVICE SHUTDOWN IS A MECHANICAL SWITCH THAT REQUIRES TWO BUTTONS ON THE FRONT OF THE DEVICE TO BE PRESSED SIMULTANEOUSLY. THE RETURNED DEVICE WAS FOUND TO OPERATE WITHIN SPECIFICATIONS AND THE EVENTS DESCRIBED IN THE USER FACILITY REPORT COULD NOT BE REPRODUCED. MANUFACTURE AND TEST RECORDS INDICATE THE DEVICE WAS ASSEMBLED ACCORDING TO CONTROLLED, PREDEFINED PROCEDURES AND ALL TESTING MET SPECIFICATION. THERE WERE NO ERRORS OR DEVIATIONS FOUND IN THE DEVICE HISTORY RECORD NOR ANY INDICATION THAT THE DEVICE WAS DEFECTIVE IN ANY WAY. A FINAL CONCLUSION WILL BE INCLUDED WITH THE FOLLOW-UP REPORT BUT AT THIS TIME WE HAVE IDENTIFIED NO DEFECTS WITH THE DEVICE, IT PERFORMS WITHIN SPECIFICATIONS AND WE HAVE NOT BE ABLE TO REPRODUCE THE ADVERSE EVENT AS DESCRIBED IN THE USER FACILITY REPORT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH THE SYNAPSE BIOMEDICAL DIAPHRAGM PACING SYSTEM (DPS) DEVICE (B)(6) 2015. THE IMPLANTING SURGEON CONTACTED A SYNAPSE BIOMEDICAL REPRESENTATIVE ON (B)(6) 2016 REPORTING THAT THE PATIENT HAD DIED. HE STATED THAT THE MOTHER OF THE PATIENT HAD LEFT THE PATIENT ALONE WHILE USING THE DPS AND OFF THE MECHANICAL VENTILATOR. WHEN SHE CAME BACK THE PATIENT WAS NOT BREATHING AND THE DPS WAS OFF. ADDITIONAL INFORMATION CAN BE FOUND IN USER FACILITY REPORT NUMBER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283924 NEURX DIAPHRAGM PACING SYSTEM DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPICALLY-IMPLANTED STIMULATOR OIR SYNAPSE BIOMEDICAL INC. 20-0035 20-0035-102815-3-2 00852184003281

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Death