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

Model Number 4000

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

Patient Problems Numbness (2415); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/14/2019

Event Type  Injury  

Event Description

Patient experiences gait disturbance and ataxia after essential tremor treatment.After hospitalization (without intervention) the side effects have gotten better but persist.This complaint was received retrospectively after the company visit the site and was not received before by the treating physician.

Manufacturer Narrative

This case is still under investigation.

Manufacturer Narrative

This complaint included known side effects.No malfunction was described.No new risks were recognized.

Event Description

Patient experiences gait disturbance and ataxia after essential tremor treatment.After hospitalization (without intervantion) the side effects have gotten better but persist.This complaint was received retrospectively after the company visit the site and was not received before by the treating physician.

• Brand Name: EXABLATE 4000
• Type of Device: MR GUIDED FOCUSED ULTRASOUND SYSTEM
• Manufacturer (Section D): INSIGHTEC LTD; 5 nachum heth street; tirat carmel, 39120 ,; IS 39120,
• Manufacturer (Section G): INSIGHTEC LTD.; 5 nachum heth; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: lidar dvir ; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 13303730
• MDR Text Key: 284110730
• Report Number: 9615058-2022-00010
• Device Sequence Number: 1
• Product Code: POH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 12/22/2021
• Supplement Dates FDA Received: 05/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Disability