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

Model Number	20360
Health Effect - Clinical Code	Cerebral Edema (4403)
Date of Event	12/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the that the patient experienced increased edema and surgery that needed craniotomy same day of the procedure.

• Brand Name: NEUROBLATE SYSTEM
• Common Device Name: NEUROBLATE® SYSTEM
• Manufacturer (Section D): MONTERIS MEDICAL; 14755 27th avenue n; suite c; plymouth MN 55447
• MDR Report Key: 11123233
• Report Number: 3009970070-2020-00091
• Device Sequence Number: 13677270
• Product Code: GEX
• UDI-Device Identifier: 00816589020656
• UDI-Public: 00816589020656
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K131955
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/31/2020

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 01/06/2021
• 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