MAUDE Adverse Event Report: ACCURAY INCORPORATED TOMOTHERAPY SYSTEM

Lot Number NONE

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

Patient Problem Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

There is no indication of device malfunction.Radiation necrosis is a known side effect of radiation therapy.Persistent bilateral trigeminal neuralgia manifested post surgery and can result from disease progression and the secondary standard right temporal lobectomy although a contributing factor of a treatment with the tomotherapy system cannot be ruled out.

Event Description

An internal accuray employee found a clinical paper titled "radiation necrosis secondary to trigeminal nerve tomotherapy; a cautionary case study" during a literature search which described a (b)(6) patient having been treated for recurrence of a cancer tumor.The paper noted that at one year post treatment the patient started to experience confusion, reduced vision field and persistent bilateral trigeminal neuralgia (tn).The patient had undergone treatment on a tomo therapy system.

• Brand Name: TOMOTHERAPY SYSTEM
• Type of Device: TOMOTHERAPY SYSTEM
• Manufacturer (Section D): ACCURAY INCORPORATED; 1310 chesapeake terrace; sunnyvale CA 94089
• Manufacturer (Section G): ACCURAY INCORPORATED; 1310 chespeake terrace; sunnyvale CA 94089
• Manufacturer Contact: coleen coleman ; 1310 cheseapeake terrace; sunnyvale, CA 94089 ; 4087894446
• MDR Report Key: 5067287
• MDR Text Key: 25488519
• Report Number: 3003873069-2015-00002
• Device Sequence Number: 1
• Product Code: MUJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Report Date: 08/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No Information
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 73 YR