BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 5804354 · Received July 19, 2016

    Report

    Report Number
    3005868392-2016-00002
    Event Type
    Injury
    Date Received
    July 19, 2016
    Date of Event
    June 8, 2016
    Report Date
    July 8, 2016
    Manufacturer
    SYNAPSE BIOMEDICAL INC.
    Product Code
    OIR
    UDI-DI
    00852184003007
    PMA / PMN Number
    H070003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY'S CHIEF MEDICAL OFFICER (A PHYSICIAN) SPOKE TO THE ATTENDING CARDIOLOGIST AT THE HOSPITAL AND THEY BELIEVE THAT THE DEVICE MAY HAVE CONTRIBUTED TO SOME OF THE ARRHYTHMIAS OBSERVED, WHICH IS A KNOWN POTENTIAL DEVICE RISK, BUT THE DEVICE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH.

    Description of Event or Problem · 1

    THE PATIENT WAS A (B)(6) YEAR OLD FEMALE WHO SUFFERED A C5-C7 SPINAL CORD INJURY FOLLOWING SURGICAL RESECTION OF A CYST ON HER SPINE LEAVING HER WITH QUADRIPLEGIA. SHE WAS SUCCESSFULLY IMPLANTED WITH THE DIAPHRAGM PACING SYSTEM (B)(6) 2013. IN 2016 THE PATIENT'S HEALTH BEGAN TO DECLINE AND SHE WAS HOSPITALIZED EARLIER IN THE YEAR (PRECISE DATE(S) UNKNOWN) FOR TREATMENT OF SMA SYNDROME DUE TO RECENT SIGNIFICANT WEIGHT LOSS. NO CARDIAC ARRHYTHMIAS WERE NOTED DURING THAT STAY AND THE PATIENT WAS DISCHARGED. THE PATIENT FURTHER DECLINED AND WAS READMITTED TO THE SAME HOSPITAL IN (B)(6) 2016 WITH BILATERAL PULMONARY EMBOLI AND HYDRONEPHROSIS, WHICH WERE TREATED. IT WAS NOTED THAT WHEN THE DIAPHRAGM PACER WAS TURNED ON AND SHE WENT FROM POSITIVE CHEST PRESSURE VENTILATION TO NEGATIVE CHEST PRESSURE VENTILATION SHE CONSISTENTLY DEVELOPED VENTRICULAR COUPLETS AND AT ONE POINT EXPERIENCED VENTRICULAR TACHYCARDIA. AT THAT TIME ALL DIAPHRAGM PACING WAS DISCONTINUED AND VENTILATION WAS MAINTAINED BY MECHANICAL VENTILATION ALONE THROUGH HER TRACHEOSTOMY. AN ECHOCARDIOGRAM PERFORMED AT THE TIME SHOWED INCREASED PULMONARY PRESSURES CONSISTENT WITH HER PULMONARY EMBOLI AND NO PERICARDIAL FLUID WAS NOTED. THE PATIENT CONTINUED TO DETERIORATE AND FURTHER ARRHYTHMIAS WERE OBSERVED. THE FAMILY THEN DECIDED TO WITHDRAW FURTHER SUPPORT AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456892 SYNAPSE BIOMEDICAL NEURX DIAPHRAGM PACING SYSTEM DIAPHRAGM PACER OIR SYNAPSE BIOMEDICAL INC. 20-0035 20-0035-080813-3-2 00852184003007

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention