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

Model Number 4000

Device Problem Insufficient Information (3190)

Patient Problem Muscle Weakness (1967)

Event Date 07/29/2022

Event Type  Injury  

Event Description

Physician reported patient weakness on the treated side on the evening of an essential tremor (et) treatment.The et treatment was completed with substantial tremor relief and no side effects.Patient was admitted to the hospital and given steroids.

Manufacturer Narrative

This complaint includes a known side effect.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD.; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC LTD.; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: victoria arzhannikov ; 5 nachum heth st.; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 15307813
• MDR Text Key: 298774627
• Report Number: 9615085-2022-00020
• 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
• Report Date: 08/28/2022

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: SYS942000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2022
• Initial Date FDA Received: 08/28/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Hospitalization