MAUDE Adverse Event Report: WHOLE BRAIN RADIATION; RADIATION THERAPY TREATMENT SYSTEM

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

Patient Problems Death (1802); Cancer (3262)

Event Date 07/27/2016

Event Type  Death  

Event Description

Clinical t3nsm1 gentleman with metastatic disease to liver, brain, bilateral lung, possibly bone, mediastinum, mesenteric lymph node and brain mets identified on (b)(6) 2016.Pt began whole brain radiation on (b)(6) 2016.Pt was admitted to the hospital on (b)(6) 2016 with altered mental status and frequent falls.Ct of head/brain; chest/abd/pelvis both performed (b)(6) 2016 showed multiple infratentorial and supratentorial metastases.Worsening metastatic disease in the chest and osseous structures, multiple liver metastasis and focal lesions in the right kidney.Pt was discharged to hospice on (b)(6) 2016.Pt passed away in hospice on (b)(6) 2016.Therapy dates: (b)(6) 2016.Diagnosis or reason for use: brain metastasis.

• Brand Name: WHOLE BRAIN RADIATION
• Type of Device: RADIATION THERAPY TREATMENT SYSTEM
• MDR Report Key: 6556792
• MDR Text Key: 74907381
• Report Number: MW5069656
• Device Sequence Number: 1
• Product Code: MUJ
• 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: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: 12 DAYS X 400 CGY; WHOLE BRAIN RADIATION
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 57 YR
• Patient Weight: 97