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 Problem Ambulation Difficulties (2544)

Event Date 01/14/2023

Event Type  Injury  

Event Description

Worsening of preexisting gait disturbance after essential tremor treatment.At the three month follow up, the patient's gait improved but did not recover to the same level as before the treatment.Patient did not require rehabilitation.

Manufacturer Narrative

Known risk of the device.No new risk has been recognized.No device malfunction.System performed as expected.

• 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: 17132662
• MDR Text Key: 317207199
• Report Number: 9615058-2023-00017
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461021
• UDI-Public: 01072900154610211200907214087
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 06/15/2023

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: SYS940354
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/17/2023
• Initial Date FDA Received: 06/15/2023
• 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
• Patient Age: 45 YR
• Patient Sex: Male