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

Model Number 4000

Patient Problem Cognitive Changes (2551)

Event Date 02/09/2024

Event Type  Injury  

Event Description

Subject underwent mr-guided focused ultrasound mesencephalotomy on (b)(6) 2024 for medication-refractory pain associated with head & neck cancer.The subject developed obtundation immediately from the procedure for less than 12 hours and then was somnolent/sleepy for 7 days before returning to baseline level of consciousness.This required observation in the intensive care unit, but no intubation or assisted ventilation.

• Brand Name: EXABLATE NEURO FOCUSED ULTRASOUN
• Type of Device: MR-GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD.; dallas TX
• MDR Report Key: 19173958
• MDR Text Key: 341076570
• Report Number: MW5154162
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4000
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White