MAUDE Adverse Event Report: INSIGHTEC 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 11/05/2019

Event Type  Injury  

Manufacturer Narrative

The retrospective analysis has not indicated any technical failures of the system.Treatment parameters were in the typical range observed.The system was found to be in spec and as expected.No new risk recognized.No new recommendations or corrective actions.

Event Description

After brain treatment of essential tremor, at 24 hours post-treatment follow up, patient presented slight left facial droop.No additional or longer term follow up data is available.

• Brand Name: EXABLATE 4000
• Type of Device: MR-GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC; 5 nachum heth street; 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC; 5 nachum heth; tirat carmel, ; IS
• Manufacturer Contact: meital trank ; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 9435055
• MDR Text Key: 173325997
• Report Number: 9615058-2019-00018
• 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: 12/08/2019

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: SYS004000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability