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 Problem Taste Disorder (4422)

Event Date 10/07/2022

Event Type  Injury  

Manufacturer Narrative

This complaint includes known side effects for essential tremor treatment.No new risks were identified.In case more details become available follow up report will be submitted.

Event Description

Loss of taste (dysgeusia).Following essential tremor treatment.

Manufacturer Narrative

No technical failures of the system detected.Treatment parameters were in line with the typical range.The system performance was found to be according to spec and as expected.This complaint includes known side effects for essential tremor treatment.No new risks were identified.

Event Description

Loss of taste (dysgeusia) following essential tremor treatment.

• 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: lidar dvir ; 5 nahum heth street; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 16616772
• MDR Text Key: 312009717
• Report Number: 9615058-2023-00009
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461091
• UDI-Public: 01072900154610911210225214227
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/08/2023

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: SYS942200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2023
• Initial Date FDA Received: 03/26/2023
• Supplement Dates Manufacturer Received: 02/24/2023
• Supplement Dates FDA Received: 05/07/2023
• 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