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	Emotional Changes (1831); Unspecified Infection (1930); Seizures (2063); Weakness (2145)
Date of Event	09/10/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following an ablation procedure, the patient experienced 3-4 episodes of non-convulsive seizures and transient left sided weakness (upper extremity and lower extremity).The hospital course was complicated by diabetic ketoacidosis (dka) and a clostridium difficile (c.Diff) infection, increased psychosis and paranoia, as well as episodes of unresponsiveness and staring spells in hospital with unknown etiology.The patient was hospitalized and received steroids and anticonvulsants.It was noted that the patient's dka was a result of the patient's poorly controlled type 2 diabetes which was then further complicated by the high dose steroids she was on during the hospitalization.The c.Diff infection had unclear etiology, but was acquired while admitted in the hospital for the adverse event.The patient also had an electroencephalogram and an electrocardiography performed.The patient was discharged from the hospital and into hospice on (b)(6) 2017.If additional information is received, a follow up report will be submitted.
Additional Manufacturer Narrative
The patient adverse event is a known risk of brain 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: 6912414
• Report Number: 3009970070-2017-00153
• Device Sequence Number: 124604
• 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): 10/03/2017

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: 09/21/2017
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 05/24/2018
• 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: Hospitalization; Required Intervention