MAUDE Adverse Event Report: INSIGHTEC LTD. EXABLATE 4000; MR GUIDED FOCUSED ULTRASOUND SYSTEM

Model Number 4000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Speech Disorder (4415)

Event Date 03/13/2024

Event Type  Injury  

Event Description

Patient was treated using focused ultrasound on the left side for essential tremor on the right hand.During the treatment, the patient developed dysarthria, and facial weakness.

Manufacturer Narrative

No new risk has been recognized.Dysarthria and facial weakness are known side effects listed in the information for prescribers.The investigation has not yet been completed and this report will be updated with the finalized investigation.

Event Description

Patient was treated using focused ultrasound on the left side for essential tremor on the right hand.During the treatment, the patient developed dysarthria,and facial weakness.

Manufacturer Narrative

Treatment parameters were in line with the typical range.No new risk has been recognized.Dysarthria and facial weakness are known side effects listed in the information for prescribers.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD.; 5 nahum heth street; tirat carmel, 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC LTD.; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: may zimmerman ; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 19103653
• MDR Text Key: 340105019
• Report Number: 9615058-2024-00014
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/27/2024

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
• Device Catalogue Number: SYS942503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 05/27/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Disability
• Patient Sex: Male