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

Model Number 4000

Device Problem Insufficient Information (3190)

Patient Problems Muscle Weakness (1967); Balance Problems (4401)

Event Type  Injury  

Manufacturer Narrative

The complaint was posted on the company (b)(6) page.There were not enough details to locate the site, the specific treatment or the treating physician.Not enough details to investigate.The complainant received post back that he should contact his treating physician or contact insightec formal website.

Event Description

This information was received from a (b)(6) post.The patient's wife stated the patient has balance issue due to muscle weakness following essential tremor treatment.

• 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: 10817176
• MDR Text Key: 215532968
• Report Number: 9615058-2020-00022
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/10/2020

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: No Information
• Device Model Number: 4000
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/10/2020
• 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