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 Shaking/Tremors (2515); Ambulation Difficulties (2544)

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.

Event Description

This complaint was posted on insightec (b)(6) page.According to the post, the patient went through a brain treatment, to address essential tremor.The patient reported a resolution of the right hand tremor.The patient listed the following effects: " can no longer play the piano or write legibly or walk steadily".Based on the available information, the company does not have enough details to locate the site or the treating physician.The complainant received a post back that she should reach his treating physician or contact insightec formal website.No further information was received regarding this case so far.

Manufacturer Narrative

There were not enough details to locate the site, the specific treatment or the treating physician.Not enough details to investigate.

Event Description

This complaint was posted on insightec facebook page.According to the post, the patient went through a brain treatment, to address essential tremor.The patient reported a resolution of the right hand tremor.The patient listed the following effects: " can no longer play the piano or write legibly or walk steadily".Based on the available information, the company does not have enough details to locate the site or the treating physician.The complainant received a post back that he should reach his treating physician or contact insightec formal website.Another post was received from the same pateint added more symptoms "the anterior third of the tongue is partially numb and trouble speaking clearly".The company still does not have enough details to locate the site or the treating physician.The complainant received again post back that he should reach his treating physician or contact insightec formal website.No further information was received regarding this case so far.

• 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
• MDR Report Key: 9999868
• MDR Text Key: 191832972
• Report Number: 9615058-2020-00009
• 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,Followup
• Report Date: 06/14/2020

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: 03/30/2020
• Initial Date FDA Received: 04/27/2020
• Supplement Dates Manufacturer Received: 03/30/2020
• Supplement Dates FDA Received: 06/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability