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 Pain (1994); Numbness (2415)

Event Date 08/20/2018

Event Type  Injury  

Manufacturer Narrative

The retrospective analysis has not indicated any technical failures or erroneous operation of the system.Treatment parameters were in line with typical range.The system performance was found to be according to spec and as expected.No new risk was recognized.On follow up mr images, lesion was seen in the targeted location, with extended hyperintensity (edema) in the surroundings which shrank over time.

Event Description

A patient was treated for essential tremor as part of a clinical trial in (b)(6).On the evening of the treatment day, the patient presented slight numbness in the right-side lip and 1-3 fingers.At week 1 visit, the patient reported the numbness.Investigator suspected cheiro-oral syndrome due to "thalamic coagulation".At month 1 visit, the subject complained about hyperalgesia and abnormal perception of the right hand indicating thalamic pain.At 1 year visit (1 year and 3 months after the treatment date), these symptoms persist.The patient presented with complains characteristic of thalamic pain as the major cause of interference with daily activities.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC LTD; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: meital trank ; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 9637776
• MDR Text Key: 176760198
• Report Number: 9615058-2020-00001
• Device Sequence Number: 1
• Product Code: POH
• 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: 01/28/2020

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: No Information
• Device Model Number: 4000
• Device Catalogue Number: SYS940352
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2019
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 46 YR