SBRT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-13 for SBRT manufactured by .

Event Text Entries

[16893567] Patient was enrolled into the (b)(6) study on (b)(6) 2013. The patient received sbrt on (b)(6) 2013 for a total of 2400cgy. The patient had been in follow-up without recurrence of disease as of last scan done in (b)(6) 2014. Per family, patient developed coughing with severe hemoptysis, patient arrived via ems at outside medical center in cardiac arrest and expired in the ed on (b)(6) 2014. The pi has determined that the event is a rare occurrence and late toxicity, likely related to sbrt where the large blood vessels around the heart may have hemorrhaged. The ctcae 4. 03 gradable event of bronchopulmonary hemorrhage grade 5 is being reported and is likely related to sbrt. Cardiac arrest is secondary to this event. No additional information is available and autopsy was not performed per family wishes. Diagnosis for use: adenocarcinoma lung, sbrt.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5040803
• MDR Report Key: 4538362
• Date Received: 2015-02-13
• Date of Report: 2015-02-12
• Date of Event: 2014-12-19
• Date Added to Maude: 2015-02-25
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: SBRT
• Generic Name: SBRT
• Product Code: IXQ
• Date Received: 2015-02-13
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2015-02-13