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

Model Number 4000

Device Problem Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Lethargy (2560)

Event Date 11/09/2023

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 the patient was treated for essential tremor using focused ultrasound.On (b)(6) 2023 the patient became more lethargic and less interactive.On (b)(6) 2023 the tremor got worse and the patient developed hand weakness.

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.The site reported that the patient history included a fall which caused a skull fracture, sometime ahead of the procedure.It can be assumed that this event may be a result of a pre-condition of the patient and of host tissue response.

Event Description

On (b)(6) 2023, patient was treated for essential tremor using focused ultrasound with no side effects.Following treatment, the patient experienced dizziness and fell and was admitted to the er.The patient was admitted two more times to the er as a result of dizziness and falling.

• 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: 18950859
• MDR Text Key: 338255915
• Report Number: 9615058-2024-00010
• 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 Sex: Male