MAUDE Adverse Event Report: RADIATION THERAPY TREATMENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 07/20/2017

Event Type  Death  

Event Description

Voluntary submission of report for pt who passed away while on treatment on institutional trial of whole brain radiation for treatment of multiple metastases.Pt with nsclc metastatic to brain on institutional protocol for wbrt using imrt to spare the hippocampus.Per pt's wife, pt fell asleep in his chair and passed away in his sleep.Coroner of (b)(6) indicated to treating radiation oncologist, dr (b)(6), no foul play or trauma involved.Per dr (b)(6), death was presumed to be progressive disease and advanced age.Pt died in his home, no hospitalization or tests performed.Was taken to medical investigator.Coroner report is pending.Per study protocol, wbrt using imrt to spare hippocampus.Received 7 fractions wbrt and 4 fractions palliative rt to hip at time of death.Received 400 cgy to brain daily.Cumulative dose 2800 cgy at time of death.Received 400 cgy daily to hip beginning (b)(6) 2017.Received 4 fractions.Cumulative dose 1600 cgy at time of death.

• Brand Name: RADIATION THERAPY TREATMENT
• Type of Device: RADIATION THERAPY TREATMENT
• MDR Report Key: 6739714
• MDR Text Key: 81026686
• Report Number: MW5071177
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 80 YR
• Patient Weight: 74