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

Model Number 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Numbness (2415)

Event Date 02/28/2018

Event Type  Injury  

Manufacturer Narrative

The system technical performance during treatment was thoroughly reviewed; no technical issues were found.No system malfunction occurred.All sonication parameters were within the normal ranges with no exceptional usage.

Event Description

The patient underwent exablate thalamotomy for essential tremor and no side effects were observed on the day of treatment.The patient reported the numbness to the site at there 1-month visit, on (b)(6) 2018, stating that the numbness began during treatment.At this point, the site was not certain whether the symptom was transient or permanent.At his 6 months visit, on (b)(6) 2018, the patient stated that his condition had not improved, and he still had significant numbness and pain in the right hand and arm; the pain report was not reported at 1-month.Insightec received the sae report on (b)(6) 2018.The patient has consulted with the site neurologist but is not receiving any sort of medication or treatment for the numbness.The patient is being treated with pain medication.At this time, there is no additional information.

• Brand Name: EXABALTE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD; 5 nachum heth street; tirat carmel, 31290 ; IS 31290
• Manufacturer (Section G): INSIGHTEC, LTD,; 5 nachum heth street; tirat carmel, is 31290 ,; IS 31290,
• Manufacturer Contact: idan cohen ; 5 nachum heth street; tirat carmel, is 31290 ; IS 31290
• MDR Report Key: 8543350
• MDR Text Key: 142880417
• Report Number: 9615058-2018-00005
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2018

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: SYS940350
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2013
• 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
• Patient Age: 76 YR