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 Paresthesia (4421)

Event Date 12/19/2021

Event Type  Injury  

Event Description

Physician reported that patient had a changed sensation at the tip of the tongue especially with ingestion of solid food items.This side effect persisted during a three month follow up visit.

Manufacturer Narrative

This complaint included known side effects.No new risks were identified.Incident is not due to any device failure or malfunction.

Event Description

The patient was treated on (b)(6) 2021 for essential tremor, and no side effect was present during and right after treatment.On 19-dec-2021 the physician reported that patient had a changed sensation at the tip of the tongue especially with ingestion of solid food items.This side effect persisted during a three-month follow up visit.

Manufacturer Narrative

This complaint included known side effects.No new risks were identified.Technical parameters were in line with the typical range incident is not due to any device failure or malfunction.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD.; 5 nahum heth street; tirat carmel, 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC LTD.; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: lena taratetsky ; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 15090505
• MDR Text Key: 296467638
• Report Number: 9615085-2022-00016
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461091
• UDI-Public: 01072900154610911211024214242
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P150038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/14/2022

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 Model Number: 4000
• Device Catalogue Number: SYS942503
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/20/2022
• Initial Date FDA Received: 07/24/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 77 YR
• Patient Sex: Male