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

Model Number 4000

Device Problem Insufficient Information (3190)

Patient Problems Numbness (2415); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

The (b)(6) post could not be confirmed with the treating physician.Not enough details to locate the specific treatment.Not enough details to investigate.

Event Description

This complaint was posted on company (b)(6).The patient mentioned that he underwent essential tremor treatment "last october" and described in the post the following side effects: "cannot control spasm movements", affected balance, taste issue and tongue numbness.

• Brand Name: EXABLATE 4000
• Type of Device: MR-GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC; 5 nahum heth; 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: 10400577
• MDR Text Key: 202709188
• Report Number: 9615058-2020-00014
• 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: 08/13/2020

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: 07/17/2020
• Initial Date FDA Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: No
• 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