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 Paresis (1998); Ambulation Difficulties (2544)

Event Date 06/13/2023

Event Type  Injury  

Event Description

Patient was treated for essential tremor on (b)(6) 2023.During the treatment, the patient experienced slight ataxia.On (b)(6) 2023 patient experienced both hemiparesis and ataxia which was slowly improving.On (b)(6) 2023 the physician updated that the patient was showing slow improvement.

Manufacturer Narrative

No malfunction was detected.Known risk of the device.No new risk has been recognized.Treatment parameters were in line with the typical range.

Event Description

Patient was treated for essential tremor on (b)(6) 2023.During the treatment, the patient experienced slight ataxia.On (b)(6) 2023, patient experienced both hemiparesis and ataxia which was slowly improving.On (b)(6) 2023, the physician updated that the patient was showing improvement on the remaining "slight hemiparesis" for which he is receiving physical therapy.

Manufacturer Narrative

No malfunction was detected.Known risk of the device.No new risk has been recognized.Treatment parameters were in line with the typical range.

• 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: 17659876
• MDR Text Key: 322360997
• Report Number: 9615058-2023-00023
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461091
• UDI-Public: 01072900154610911221206214276
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 11/16/2023

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: SYS942503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 08/01/2023
• Supplement Dates FDA Received: 11/16/2023
• 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): Hospitalization; Disability; Life Threatening
• Patient Sex: Male