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

Model Number 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paralysis (1997); Weakness (2145); Patient Problem/Medical Problem (2688)

Event Date 05/11/2018

Event Type  Injury  

Manufacturer Narrative

The system technical performance during treatment was thoroughly reviewed;no technical issues were found.No system malfunction occurred.

Event Description

On (b)(6) 2018, insightec was notified, that patient who was treated on (b)(6) 2018, reported of on some taste issues, ataxia and rle weakness.By the october 1st follow up, the patient reported very mild right sided drooling and incoordination.

Event Description

On november 27, 2018, insightec was notified that a patient who was treated for essential tremor on (b)(6) 2018 at (b)(6), reported mild right side drooling and incoordination.Insightec later learned that upon examination, the only issue the patient was experiencing was the taste disturbance.This report is submitted to correct the original report submitted to fda.

• Brand Name: EXABALTE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 8543551
• MDR Text Key: 142875445
• Report Number: 9615058-2018-00013
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• PMA/PMN Number: P1500038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2018,06/04/2019

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: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: SYS004000-AA
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/27/2018
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 04/24/2019
• Supplement Dates Manufacturer Received: 11/27/2018
• Supplement Dates FDA Received: 06/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 77 YR