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 Myocardial Infarction (1969)

Event Date 08/05/2022

Event Type  Death  

Event Description

Patient was treated on (b)(6) 2022, for essential tremor (et).The patient left with tremor relief and paresthesia in his right leg that he mentioned was starting to resolve.Post op mr images that were taken immediately after the treatment showed a small, focal lesion with no visible necrotic core and little edema.On (b)(6), patient complained of chest pain which resolved with antacids.This was suspected as heartburn.On (b)(6) (11 days after treatment), patient developed chest pain again, and was admitted to the hospital where he was diagnosed with a myocardial infarction and treatment was attempted in the cathlab.He died shortly thereafter.

Manufacturer Narrative

No device malfunction was detected.Treatment parameters were in line with the typical range.The system performance was found to be as expected.No new risks were identified.The internal investigation analysis could not find any relation between the treatment and patient's heart attack.This is in line with the neurosurgeon's view who advised it seems unlikely that his heart attack was directly related to treatment.

• 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: may zimmerman ; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 15468883
• MDR Text Key: 300419208
• Report Number: 9615085-2022-00025
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461091
• UDI-Public: 01072900154610911200705214229
• 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: 09/22/2022

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: SYS942200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/23/2022
• Initial Date FDA Received: 09/22/2022
• 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; Death