BEUDAMED
    FDA Adverse Event Death Summary report: N

    NEURX DIAPHRAGM PACING SYSTEM

    MDR report key: 3444930 · Received October 25, 2013

    Report

    Report Number
    3005868392-2013-00002
    Event Type
    Death
    Date Received
    October 25, 2013
    Date of Event
    July 13, 2013
    Report Date
    October 24, 2013
    Manufacturer
    SYNAPSE BIOMEDICAL INC
    Product Code
    OIR
    PMA / PMN Number
    H100006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT IS A (B)(6) MALE WITH ALS WITH CHRONIC RESPIRATORY FAILURE WITH MIP OF 40 AND FVC OF 55 PERCENT PREDICTED. ON FLUOROSCOPY, HE HAD BILATERAL MOVEMENT OF HIS DIAPHRAGM. HE MET THE INDICATIONS FOR DIAPHRAGM PACING PLACEMENT. PAST MEDICAL HISTORY INCLUDES COPD FROM SMOKING (QUIT 1985) AND HYPERTENSION. FAMILY MEDICAL HISTORY IS SIGNIFICANT FOR FATHER HAVING DEEP VEIN THROMBOSIS WITH PULMONARY EMBOLISM. PT ALSO HAD SOME DYSPHAGIA AND WITH DECLINING FVC, THE PLAN WAS FOR DIAPHRAGM PACING WITH GASTROSTOMY TUBE PLACEMENT. THE PT UNDERWENT AN UNEVENTFUL SURGERY ON (B)(6). HE HAD PROPHYLAXIS FOR DEEP VEIN THROMBOSIS WITH BOTH VENODYNE BOOTS AND SUBCUTANEOUS HEPARIN. THE PT WAS DISCHARGED ON POST OPERATIVE DAY 1. HE BECAME SUDDENLY SHORT OF BREATH AND WAS EVALUATED IN THE EMERGENCY ROOM ON (B)(6) AND WAS FOUND TO HAVE MULTIPLE FILLING DEFECTS BILATERALLY IN THE PULMONARY ARTERIES. THERE WAS ALSO EVIDENCE OF SOME HEART STRAIN ON CT AND ELEVATED TROPONIN FROM DEMAND ISCHEMIA IN SETTING OF EXTENSIVE PULMONARY EMBOLISM. PT WAS STARTED ON HEPARIN AND SUPPORTED IN THE ICU WITH OXYGEN AND NON-INVASIVE VENTILATION. HE WAS FOUND TO HAVE A FEMORAL CLOT. VASCULAR SURGERY WAS CONSULTED AND THEY RECOMMENDED PLACEMENT OF A CAVAL FILTER TO PREVENT A SECOND PULMONARY EMBOLISM IN A COMPROMISED PT. THE PT AND FAMILY DECLINED THIS THERAPY. THE PT ALSO HAD AN ELEVATED WBC AND WAS CONSIDERED TO HAVE ASPIRATION PNEUMONIA. HE WAS STARTED ON BROAD SPECTRUM ANTIBIOTICS. HE ALSO DEVELOPED ATRIAL FIBRILLATION WITH RAPID VENTRICULAR RESPONSE THAT WAS MANAGED MEDICALLY. THE PT WAS MEDICALLY MANAGED INITIALLY BUT BECAME PROGRESSIVELY HYPERCARBIC WITH PCO2 ELEVATING EVEN ON NONINVASIVE VENTILATION. THE FAMILY AND PT DECLINED FURTHER INVASIVE VENTILATION EVEN WITH THE POSSIBILITY OF RECOVERING FROM THIS EVENT OF PULMONARY EMBOLISM WITH FURTHER COMPLICATION OF PNEUMONIA. THEY STARTED COMFORT CARE ONLY AND STOPPING ALL THERAPIES. HE EXPIRED ON (B)(6) 2013. SOURCE OF INFORMATION WAS BLINDED HOSPITAL RECORDS AND AE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548457 NEURX DIAPHRAGM PACING SYSTEM DIAPHRAGMATIC/PHRENIC NERVE LAPAROSCOPIC OIR SYNAPSE BIOMEDICAL INC 20-0045 20-0045-052013-10-9

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death