MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20360
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	12/05/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was received via legal summons.Internal records show no complaints related to this procedure.
Event or Problem Description
It was reported that following an ablation procedure, the patient experienced severe brain damage as a result of the procedure with corresponding loss of function.There were no additional patient complications reported in relation to this event.

• Brand Name: NEUROBLATE® SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 8846476
• Report Number: 3009970070-2019-00057
• Device Sequence Number: 19473561
• Product Code: GEX
• UDI-Device Identifier: 00816589020656
• UDI-Public: 00816589020656
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173305
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2019

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
• Operator of Device: Health Professional
• Device Model Number: 20360
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2019
• Initial Report FDA Received Date: 07/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other