MAUDE Adverse Event Report: RADIATION THERAPY DEVICE; SOURCE, BRACHYTHERAPY, RADIONUCLIDE

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

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 05/21/2020

Event Type  Death  

Event Description

Sudden death; patient name- (b)(6), family informed heart attack was cause of death.Treated by (b)(6).Injection ceftriaxone sodium 250 mg.Other providers with (b)(6).Medications prescribed include hctz 25 / triamterene 37.5; ndc # 00378-1352-01; allopurinol 300 mg; losartan ndc # 13107-0197-99; 100 mg; ndc # 13107-0197-99.Insertion of radiation devices in prostate gland few hours prior to death.Targeted radiation therapy (b)(6); referred by (b)(6).Fda safety report id# (b)(4).

• Brand Name: RADIATION THERAPY DEVICE
• Type of Device: SOURCE, BRACHYTHERAPY, RADIONUCLIDE
• MDR Report Key: 10157592
• MDR Text Key: 195383780
• Report Number: MW5094995
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 72 YR
• Patient Weight: 82