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); No Code Available (3191)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

No technical issues were found.No system malfunction occured.

Event Description

On (b)(6) 2019 insightec was made aware of customer complaint regarding event following brain treatment with exablat 4000 system.The patient underwent exablate thalamotomy for essential tremor treatment in (b)(6) on (b)(6) 2019.Immediately post treatment the patient presented ataxia and at 1-week follow-up (b)(6) complained about hemiparesis (side weakness), which was verified by neurological examination at the site.The site recommended on physiotherapy.According to the site ((b)(6) report, the patient suffered from weakness in the right hand and leg and needed physical therapy.On (b)(6), (b)(6) team updated that patient is improving, going without a walker and in overall good status.

• 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: 8490157
• MDR Text Key: 141166221
• Report Number: 9615058-2019-00003
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 04/08/2019

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: SYS940200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2015
• 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