MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION NEUROBLATE® SYSTEM

Model Number	20360
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Seizures (2063); Confusion/ Disorientation (2553); Patient Problem/Medical Problem (2688)
Date of Event	04/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following an ablation procedure, the patient experienced acute encephalopathy, confusion, poor attention/lethargy, difficulty with speech, diplopia, 6th left cranial nerve palsy and possible seizure activity.The patient was prescribed a 3% saline bolus and started on the 3% infusion which improved/resolved some of the adverse events.The patient later received physical and occupational therapy and was eventually transferred to a neuro-rehabilitation service where he continued to receive therapy for about 2 weeks.The patient also received day 1 of cycle 1 of pembrolizumab on (b)(6) 2017.The event resolution is unknown.If additional information is received, a follow up report will be submitted.
Event or Problem Description
Additional information received indicated that the encephalopathy was not related to the ablation surgery.

• 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: 6983167
• Report Number: 3009970070-2017-00156
• Device Sequence Number: 16423433
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,study
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2017

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: 09/29/2017
• Supplement Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 12/06/2017
• 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