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 Movement Disorder (4412)

Event Date 12/12/2020

Event Type  Injury  

Manufacturer Narrative

This case is still under investigation.

Event Description

Insightec initially received a report as to this event directly from the patient via contact with an insightec educator in (b)(6) 2021.The patient indicated at that time that she experienced a stroke four days after the treatment and sought treatment for such by physicians at a local hospital.The patient further indicated that her physicians advised that the stroke was most likely unrelated to treatment.Based on the limited information available at that time as conveyed by the patient, the company's determination was that the event is unrelated to the treatment or the device.The patient followed up approximately 11 months later via a complaint reported on the insightec website, reiterating that she had a stroke four days after treatment and also indicating that she was continuing to experience "erratic and uncontrollable movements" and tremors in her arms and hands.

Manufacturer Narrative

This complaint included known side effect.No new risks were identified.No device malfunction was detected.Treatment parameters were in line with the typical range.

Event Description

Insightec initially received a report as to this event directly from the patient via contact with an insightec educator in january 2021.The patient indicated at that time that she experienced a stroke four days after the treatment and sought treatment for such by physicians at a local hospital.The patient further indicated that her physicians advised that the stroke was most likely unrelated to treatment.Based on the limited information available at that time as conveyed by the patient, the company's determination was that the event is unrelated to the treatment or the device.The patient followed up approximately 11 months later via a complaint reported on the insightec website, reiterating that she had a stroke four days after treatment and also indicating that she was continuing to experience "erratic and uncontrollable movements" and tremors in her arms and hands, worse in the left, untreated arm.

• 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: 13174065
• MDR Text Key: 283475558
• Report Number: 9615058-2022-00001
• Device Sequence Number: 1
• Product Code: POH
• UDI-Device Identifier: 07290015461021
• UDI-Public: 01072900154610211200514214082
• 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: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

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 Operator: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: SYS940000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 01/06/2022
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/03/2020
• 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 Sex: Female