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 01/17/2023

Event Type  Injury  

Manufacturer Narrative

This complaint includes known side effects for essential tremor treatment.The complaint was received through the company website with very limited information.Therefore, the investigation of the event has yet to be completed and any additional findings will be reported in a follow up report.

Event Description

Following essential tremor treatment on the right side of the body, patient reported speech difficulties and right sided weakness.

Manufacturer Narrative

No malfunction detected.No new risk has been recognized.Treatment parameters were in line with the typical range.This complaint includes known side effects for essential tremor treatment.

Event Description

Patient was treated for essential tremor on the right side of the body (right hand tremor).After the treatment, patient was reported to have nearly complete tremor relief.Patient later reported speech difficulties and right sided weakness.

• 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: 17497661
• MDR Text Key: 320767091
• Report Number: 9615058-2023-00021
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• PMA/PMN Number: P150038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2023

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 Model Number: 4000
• Device Catalogue Number: SYS942202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/12/2023
• Initial Date FDA Received: 08/10/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 12/03/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability