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

Model Number 4000

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Headache (1880); High Blood Pressure/ Hypertension (1908); Nerve Damage (1979)

Event Date 10/03/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

This complaint was posted on insightec (b)(6) page.The patient stated that she had brain treatment for essential tremor on (b)(6) 2018 and since then she had "lots of effects: high bp, headaches and tongue nerves damaged".The patient also reported that some of the side effects "got better like balance" (no further details).Based on the available information, the company has no ability to locate the site or the treating physician.The complainant received a post back that she should reach her treating physician or contact insightec formal website.No further information was received regarding this case so far.

Event Description

This complaint was posted on insightec facebook page.The patient stated that she had brain treatment for essential tremor on (b)(6) 2018 and since then she had "lots of effects: high bp, headaches and tongue nerves damaged".The patient also reported that some of the side effects "got better like balance" (no further details).The complainant received a post back that she should reach her treating physician or contact insightec formal website.Addtional information: the patient submitted a complaint through the company website with more details about the treatment, so further investigation was possible.The patient reported she was experiencing residual side effects from her treatment, including headaches, increased blood pressure, weakness on her right side (face, arms and legs), decreased bladder control and taste disturbance.According to treatment report, no side effects appeared at any point during the treatment and treatment completed with tremor control and no side effects.At the 3 months follow up visit the patient reported to the neurologist and neurosurgeon that she had some sensory side effects and mild gait disequilibrium.She also complained of headaches that the site believed were unrelated to treatment.At the 6 months follow up visit the patient reported to the neurologist and neurosurgeon that she still had some residual perioral numbness and taste change.Her gait had largely improved, and her headaches had also largely resolved.The treating physician concluded that except for the change in taste, all the other side effects (headaches, increased blood pressure, weakness, decreased bladder control) were not associated with the treatment.

Manufacturer Narrative

This review of this treatment has not indicated any technical failures of the system.Treatment parameters were in line with typical range.The system performance was found to be according to spec and as expected.No new risk was recognized.

• 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: 9823076
• MDR Text Key: 187758885
• Report Number: 9615058-2020-00005
• 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
• Device Catalogue Number: SYS940352
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/13/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 02/13/2020
• 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
• Patient Age: 78 YR