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Death reported2013-02-13FDA MAUDE2950679-2013-00003CyberKnife
CyberKnife — Death report filed with FDA (MAUDE). A MAUDE report does not establish that the device caused the outcome. Reported narrative: 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.
cause not established2950679-2013-00003AccurayRead the record ↗