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 Cardiac Arrest (1762)

Event Date 09/19/2023

Event Type  Death  

Event Description

Patient was treated for essential tremor on (b)(6) and no side effects were observed after the procedure.On (b)(6) the patient passed away in his sleep.

Manufacturer Narrative

No malfunction detected.No new risk has been recognized.Treatment parameters were in line with the typical range.The device did not cause or contribute to the event.The case is still under investigation.According to the site, the patient's cause of death was his extensive cardiac history and that the event is just coincidental.

Event Description

Patient was treated for essential tremor on (b)(6) and no side effects were observed after the procedure.On (b)(6) the patient passed away in his sleep.

Manufacturer Narrative

No malfunction detected.No new risk has been recognized.Treatment parameters were in line with the typical range.Our assessment is that the device did not cause or contribute to the event.According to the site, the patient's cause of death was his extensive cardiac history and that the event is just coincidental.

• 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: 17964226
• MDR Text Key: 326010800
• Report Number: 9615058-2023-00026
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461091
• UDI-Public: 01072900154610911210127214233
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2023

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
• Initial Date Manufacturer Received: 09/21/2023
• Initial Date FDA Received: 10/19/2023
• Supplement Dates Manufacturer Received: 09/21/2023
• Supplement Dates FDA Received: 11/16/2023
• 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): Death
• Patient Age: 75 YR
• Patient Sex: Male