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 Problem Shaking/Tremors (2515)

Event Date 10/10/2019

Event Type  Injury  

Manufacturer Narrative

This case is still under investigation.

Event Description

This complaint was received from (b)(6) page.In the post the patient complained that after treatment "the tremor and other side effect got worse".The company succeeded to locate the site (b)(6)) and the treating physician (dr.(b)(6)) , who indicated that there were no unexpected side effects after treatment.Around a week after the initial communication with the site, the local neurologist (dr.(b)(6)) performed a telephone follow up with the patient and indicated to the company that the patient had significant worsening of his balance.The complainant received a post back that he should reach his treating physician or contact insightec formal website.

Manufacturer Narrative

This review of this treatment has not indicated any technical failures 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.

Event Description

This complaint was received from insightec facebook page.In the post the pateint complained that after treatment "the tremor and other side effect got worse".The company succeeded to locate the site (cleveland clinic, florida) and the treating physician (dr.Nagel) , who indicated that there were no unexpected side effects after treatment.Around a week after the initial communication with the site, the local neurologist (dr.Jones) performed a telephone follow up with the pateint and indicated to the company that the pateint had significant worsening of his balance.The complainant received a post back that he should reach his treating physician or contact insightec formal website.This follow up report is submitted to reflect the completion of internal investigation (see section h10).

• 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
• MDR Report Key: 9975726
• MDR Text Key: 188368863
• Report Number: 9615058-2020-00008
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• PMA/PMN Number: P150038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 06/14/2020

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: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: SYS942001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 04/19/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 06/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability