MAUDE Adverse Event Report: INSIGHTEC, LTD EXABLATE NEURO; MR-GUIDED FOCUSED ULTRASOUND SYSTEM

Model Number 4000

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

Patient Problems Pain (1994); Vomiting (2144); Hyponatremia (4494)

Event Date 07/16/2020

Event Type  Injury  

Event Description

A pt initially presented with right facial pain was diagnosed in 2013 with stage 4b squamous cell carcinoma of the right tonsil and tongue.This pt enrolled in a clinical trial ((b)(6)) on (b)(6) 2020 for head and neck cancer pain and was subsequently treated with focused ultrasound on (b)(6) 2020 without any unexpected issues/ adverse events.On (b)(6) 2020 the pt presented to the emergency room with med refractory pain and being unable to eat as a result.He was treated with a percutaneous gastrostomy tube and pain mgmt.The pt was discharged on (b)(6) 2020.The pi deemed this event unrelated to the focused ultrasound procedure.

Event Description

Additional info received from reporter on 09/10/2020 for mw5096533.A pt initially presented with right facial pain was diagnosed in 2013 with stage 4b squamous cell carcinoma of the right tonsil and tongue.The pt is enrolled in a clinical trial (b)(4) on (b)(6)2020 for head and neck cancer pain and was subsequently treated with focused ultrasound on (b)(6) 2020 without any unexpected issues / adverse events.On (b)(6) 2020 the pt presented to the er with hyponatremia from persistent vomiting and was admitted to hosp.He was treated for the vomiting and hyponatremia and discharged on (b)(6) 2020.Pt pi deemed this event unrelated to the focused ultrasound procedure.

• Brand Name: EXABLATE NEURO
• Type of Device: MR-GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC, LTD; dallas TX
• MDR Report Key: 10515716
• MDR Text Key: 206571336
• Report Number: MW5096533
• Device Sequence Number: 1
• Product Code: POH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/10/2020
• 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: 0
• Patient Outcome(s): Hospitalization
• Patient Age: 63 YR
• Patient Weight: 61