{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-09-08",
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      "reporter_occupation_code": "NOT APPLICABLE",
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          "date_received": "20130315",
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      "mdr_report_key": "3012320",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20130213",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
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      "adverse_event_flag": "Y",
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      "mdr_text": [
        {
          "mdr_text_key": "19199519",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "DURING A REVIEW OF A DRAFT CLINICAL PUBLICATION, AN ACCURAY EMPLOYEE NOTICED AN ADVERSE EVENT DESCRIBED. THE PUBLICATION DESCRIBES A STUDY OF 26 PTS TREATED FROM 2007-2011. THE PTS WERE CONSIDERED INOPERABLE PTS WITH LOCALIZED LUNG TUMORS. ON PT, WHO WAS PRESENTED WITH STEROID-REFRACTORY RADIATION PNEUMONITIS AT EIGHT MONTHS POST-TREATMENT, DIED OF ACUTE RESPIRATORY FAILURE FOUR MONTHS LATER. THE PT HAD UNDERGONE A LEFT PNEUMONECTOMY PRIOR TO RECEIVING RADIATION TREATMENT. THE COMPLICATION IS A KNOWN RISK OF TREATING A TUMOR WITHIN THE GIVEN TREATMENT PARAMETERS AND TUMOR LOCATION. THE PHYSICIAN INDICATED THAT THE PLANNED TREATMENT WAS DELIVERED AS INTENDED AND THAT THE AE WAS NOT DUE TO A MALFUNCTION OF THE DEVICE."
        }
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      "manufacturer_contact_postal_code": "",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}