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

Model Number 4000

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

Patient Problems Fatigue (1849); Paralysis (1997); Patient Problem/Medical Problem (2688)

Event Date 10/12/2018

Event Type  Injury  

Event Description

On november 27, 2018, insightec was notified, that patient who was treated on (b)(6) 2018, reported of an imbalance (pulling to the right) and change in taste, and fatigue.The treatment initially resulted in complete tremor relief and no side effects were observed by the clinical team on the day of treatment.At 1m post-treatment ((b)(6)), the same symptoms were still present, but improving.Additional clinical follow-up is not currently available.

• Brand Name: EXABALTE 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 street; tirat carmel, 39120 ; IS 39120
• Manufacturer Contact: idan cohen ; 5 nachum heth street; tirat carmel, 39120 ; IS 39120
• MDR Report Key: 8543576
• MDR Text Key: 142879384
• Report Number: 9615058-2018-00015
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/26/2018

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
• Device Catalogue Number: SYS004000-AA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/28/2018
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2012
• 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
• Patient Age: 68 YR