MAUDE Adverse Event Report: INSIGHTEC LTD. EXABLATE 4000; MR GUIDED FOCUSED ULTRASOUND SYSTEM

Model Number 4000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Balance Problems (4401); Movement Disorder (4412); Speech Disorder (4415)

Event Date 06/09/2022

Event Type  Injury  

Manufacturer Narrative

This complaint included known side effects.

Event Description

The following side effects were reported following treatment: balance, speech issues, right arm weakness and coordination issues.

Manufacturer Narrative

This complaint includes known side effects for essential tremor treatment.No new risks were identified.No device malfunction was detected.Treatment parameters were in line with the typical range.

Event Description

The following side effects were reported following essential tremor treatment: right arm ataxia, balance impaired.

• 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: 15379038
• MDR Text Key: 299461294
• Report Number: 9615085-2022-00023
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

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 Operator: Health Professional
• Device Model Number: 4000
• Device Catalogue Number: SYS942202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/08/2022
• Supplement Dates Manufacturer Received: 08/11/2022
• Supplement Dates FDA Received: 02/02/2023
• 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): Disability