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 Weakness (2145); Ambulation Difficulties (2544); No Code Available (3191)

Event Date 01/15/2018

Event Type  Injury  

Manufacturer Narrative

The retrospective analysis has not indicated any technical failures or erroneous operation of the system.Edema of surrounding tissue with associated neurological deficits or symptoms is occasionally seen after tcmrgfus treatment and is described in the ifp and the study protocol as an anticipated risk; this edema usually causes transient and mild to moderate symptoms.

Event Description

Patient (pt.No.(b)(6)) was treated on (b)(6) 2018 for essential tremor (et).This treatment is part of a clinical study, (b)(6).The patient complained on gait instability in left lower extremity.The patient needed extension of hospitalization and underwent rehabilitation from (b)(6).The patient was discharged from hospital on (b)(6) 2018, by foot with some weakness remained.According to the last follow up report, that occurred on (b)(6) 2018 the patient still complained of weakness of right leg and instability of the gait.Also slight left ataxia was present.

• 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: meital trank ; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 8580836
• MDR Text Key: 144114979
• Report Number: 9615058-2019-00004
• 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
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2019

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2019
• Initial Date FDA Received: 05/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2016
• 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): Hospitalization; Disability
• Patient Age: 64 YR