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

Model Number 4000

Device Problem Insufficient Information (3190)

Patient Problems Numbness (2415); Ambulation Difficulties (2544); Taste Disorder (4422)

Event Type  Injury  

Manufacturer Narrative

The information was not confirmed with the treating physician.Based on the interview, there is not enough details to locate the specific treatment.The side effects mentioned during the interview were not questioned further; it was determined that it was not the patient's intent to raise a formal complaint but rather to share his overall experience of the procedure with the interviewer.

Event Description

During an interview preformed by insightec representative, a patient mentioned numbness in his fingers and lips, loss of taste and some gait issues that remain one year following essential tremor treatment.According to the interview the patient had trouble walking prior the treatment.Also the patient mentioned that he feels that the numbness has improved over time.

• Brand Name: EXABLATE 4000
• Type of Device: MR-GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC; 5 nahum heth street; tirat carmel, 39120 ; IS 39120
• Manufacturer (Section G): INSIGHTEC; 5 nahum heth; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: meital trank ; 5 nahum heth; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 10539574
• MDR Text Key: 207108941
• Report Number: 9615058-2020-00019
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• PMA/PMN Number: P150038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 09/16/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/17/2020
• Initial Date FDA Received: 09/16/2020
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability