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 Shaking/Tremors (2515)

Event Date 04/11/2022

Event Type  Injury  

Manufacturer Narrative

This complaint included known side effects.Tremor on the right hand seems to be unrelated and most likely due to progressional disease.No new risks were identified.

Event Description

Three months after treatment, patient reported a complaint through the company website.One month after the treatment, side effects such as tremor, numbness and gait issues began to show on the left side of the body where the treatment was performed.In addition, tremor also appeared on the right hand.

• 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: 15198368
• MDR Text Key: 297673476
• Report Number: 9615085-2022-00017
• Device Sequence Number: 1
• Product Code: POH
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2022

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: SYS942202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/10/2022
• 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