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

Model Number 4000

Device Problem Insufficient Information (3190)

Patient Problems Dizziness (2194); Ambulation Difficulties (2544)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

No new risk has been recognized.The investigation for this report has not been in completed yet.If new details are received in the investigation for this incident, this report will be updated.

Event Description

On (b)(6) 2023,patient was treated for essential tremor using focused ultrasound.On (b)(6) 2023 the patient came for a follow up with the physician due to dizziness and needed to use a walker.The patient began physical therapy on (b)(6) 2023.On (b)(6) 2024 the patient no longer required a walker but was unable to walk in a straight line.

Manufacturer Narrative

Treatment parameters were in line with the typical range.The system performance was found to be according to spec and as expected.No new risk has been recognized.No irregularities were found in the usage or operation of the system.

Event Description

On (b)(6) 2023,patient was treated for essential tremor on the left side using focused ultrasound.On (b)(6) 2023 the patient came for a follow up with the physician due to dizziness and needed to use a walker.The patient began physical therapy on (b)(6) 2023.On (b)(6) 2024 the patient no longer required a walker but was unable to walk in a straight line.

• 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: 18950860
• MDR Text Key: 338255971
• Report Number: 9615058-2024-00009
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461091
• UDI-Public: 01072900154610911220913214266
• 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: 03/21/2024

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: 02/22/2024
• Initial Date FDA Received: 03/21/2024
• 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): Disability
• Patient Age: 80 YR
• Patient Sex: Female