{
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
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      "mdr_report_key": "3069402",
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      "number_devices_in_event": "",
      "date_manufacturer_received": "20130319",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "mdr_text": [
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          "mdr_text_key": "3426885",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "ON (B)(6) 2013, AN ACCURAY EMPLOYEE LEARNED OF THE DEATHS OF TWO PTS DETAILED IN A RESEARCH PAPER (DISEASES OF THE ESOPHAGUS 2012, V:25, PG 623-629, TITLE: ESOPHAGEAL TOLERANCE TO HIGH-DOSE STEREOTACTIC ABLATIVE RADIOTHERAPY). ONE PT RECEIVED TREATMENTS FOR A LUNG TUMOR IN PARALLEL WITH CHEMOTHERAPY. SIX MONTHS AFTER TREATMENT, THE PT DEVELOPED FATAL HEMOPTYSIS (COUGHING UP OF BLOOD). THE SECOND PT RECEIVED TREATMENTS FOR A SPINAL TUMOR PARALLEL WITH CHEMOTHERAPY. FOUR MONTHS POST TREATMENT, THE PT DEVELOPED AN ESOPHAGEAL PERFORATION AND INFECTION LEADING TO DEATH. THE DOCTOR CONFIRMED THE PTS HAD BEEN TREATED CORRECTLY AND THE SYSTEM HAD NOT MALFUNCTIONED."
        },
        {
          "mdr_text_key": "10717657",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THIS WAS NOT AN ACCURAY SPONSORED STUDY. ACCURAY REGULATORY AFFAIRS PERSONNEL CONTACTED THE PRINCIPLE INVESTIGATOR OF THE STUDY FOR FURTHER DETAILS CONCERNING THE ADVERSE EVENTS. THE PRINCIPLE INVESTIGATOR COMMENTED THE TOLERANCE OF THE ESOPHAGUS TO THERAPEUTIC RADIATION WAS NOT WELL UNDERSTOOD, AND THE STUDY WAS UNDERTAKEN WITH A VIEW TO ESTABLISHING DOSE SAFETY GUIDELINES. THE STUDY CONCLUDED HIGH DOSES OF RADIATION TO THE ESOPHAGUS WITH CONCURRENT CHEMOTHERAPY ARE NOT WELL TOLERATED AND MORE CONSERVATIVE TREATMENT REGIMES THAN THOSE CURRENTLY UTILIZED SHOULD BE CONSIDERED."
        }
      ],
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}