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

Model Number 4000

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

Patient Problems Ambulation Difficulties (2544); Movement Disorder (4412)

Event Date 04/26/2023

Event Type  Injury  

Event Description

Patient developed ataxia in right arm and gait disturbance of right leg after the essential tremor treatment.The patient was admitted for monitoring and discharged after 3 days.

Manufacturer Narrative

Patient has improved over the course of two weeks.Physician expects the side effects to resolve.No malfunction was detected known risk of the device.No new risk has been recognized.

• 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 nahum heth street; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: victoria arzhannikov ; 5 nahum heth street; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 17037281
• MDR Text Key: 316299979
• Report Number: 9615058-2023-00016
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461091
• UDI-Public: 01072900154610911210526214237
• 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
• Report Date: 06/01/2023

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: SYS942000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 06/01/2023
• 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; Hospitalization