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 Twitching (2172); Patient Problem/Medical Problem (2688)

Event Date 07/17/2018

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 (on (b)(6) 2018) of twitching/spasm in treated arm.On (b)(6) 2018 patient reported less twitching/spasm in the arm and noticed delayed alteration in taste.On (b)(6) 2018 patient reported he regained some taste but only when flavors are strong, still noticed intermittent spasms.On (b)(6) 2018, taste is still affected, patient has a "phantom taste" phenomenon.Spasms are improving, but still present.

• 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
• Manufacturer (Section G): INSIGHTEC LTD; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: idan cohen ; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 8543518
• MDR Text Key: 142878050
• Report Number: 9615058-2018-00012
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 12/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: SYS004000-AA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2018
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2012
• 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: 77 YR