MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION NEUROBLATE SYSTEM; NEUROBLATE® SYSTEM

Model Number	20360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fall (1848); Weakness (2145); Patient Problem/Medical Problem (2688)
Date of Event	06/08/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following an ablation procedure the patient experienced left sided weakness and instability.It was also noted that the patient experienced a fall 2 days after discharge and hit her head.This lead to a trip to the emergency room for imaging.The patient then presented at the one month follow-up visit with a broken foot due to another fall.There were no further patient complications and the event was considered to be ongoing.
Additional Manufacturer Narrative
The patient adverse event is a known risk of brain surgery.
Additional Manufacturer Narrative
Supplement#1 had the incorrect mfr number associated with it (3009977070-2017-00139 - 1 submit date:(b)(6)2017).This submission is to correct the number on that report.
Additional Manufacturer Narrative
Supplement#1 had the incorrect mfr number associated with it (3009977070-2017-00139 - 1 submit date: november 01, 2017).This submission is to correct the number on that report.

• Brand Name: NEUROBLATE SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL CORPORATION; 14755 27th ave n; suite c; plymouth MN 55447
• MDR Report Key: 6876206
• Report Number: 3009970070-2017-00139
• Device Sequence Number: 1523541
• Product Code: GEX
• UDI-Device Identifier: 00816589020403
• UDI-Public: 00816589020403
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K162762
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/15/2020

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
• Operator of Device: Health Professional
• Device Model Number: 20360
• Device Catalogue Number: NB102
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 04/30/2018; 04/30/2018; 04/30/2018
• Initial Report FDA Received Date: 09/19/2017
• Supplement Report FDA Received Date: 10/20/2020; 05/23/2018; 10/16/2020
• 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: Required Intervention