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 Dizziness (2194); Ambulation Difficulties (2544)

Event Date 04/19/2021

Event Type  Injury  

Manufacturer Narrative

According to the available information, there is not enough information to determine what is the result of the reported "mild stroke" or if it is related to the treatment.This case is still under investigation.

Event Description

In follow up call from the clinical educator one day after essential tremor treatment the patient stated that he had some dizziness.Eight days after the conversation, in an additional follow up call from the clinical educator, the patient stated that he admitted to the hospital following a mild stroke.

Manufacturer Narrative

The retrospective analysis has not indicated any technical failures operation of the system.Treatment parameters were in line with the typical range.The system performance was found to be according to spec and as expected.No new risk was recognized.

Event Description

In follow up call from the clinical educator one day after essential tremor treatment the patient stated that he had some dizziness.Eight days after the conversation, in an addtional follow up call from the clinical educator, the patient stated that he admitted to the hospital following a mild stroke.This follow up report is submitted to reflect the completion of internal investigation (see section h10) and to update with the following: the imaging findings were misdiagnosed by er team as stroke, not knowing that these were normal post ablation findings.Furthermore the patient did experience difficulty with strength, coordination and dexterity.A recent visit to the hospital (er) did not reveal any acute abnormalities or stroke evidance.

• 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: 11884319
• MDR Text Key: 252905473
• Report Number: 9615058-2021-00011
• 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: 07/18/2021

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: SYS942200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/26/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 07/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability