MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM

Model Number	20360
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Tachycardia (2095); Patient Problem/Medical Problem (2688)
Date of Event	08/27/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that following an ablation procedure, the patient experienced diabetes insipidus, supraventricular tachycardia and atrial flutter with a 2:1 heart block.The patient had a serum osmolality of 320 and urine osmolality of 120 with urine specific gravity at 1.06, and was treated with an increase dosage of dexamethasone on (b)(6) 2018 for the diabetes.The patient was also treated with an increase in medication and ablation for the heart block.The events were considered definitely related to the surgical procedure.The diabetes was considered resolved as of (b)(6) 2018, and the other events resolved as of (b)(6) 2018.The patient was discharged to a skilled nursing facility on (b)(6) 2018.There were no further 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: 9315484
• Report Number: 3009970070-2019-00094
• Device Sequence Number: 18927531
• 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: K173305
• Number of Events Summarized: 1
• Summary Report (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): 11/13/2019

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: 10/17/2019
• Initial Report FDA Received Date: 11/13/2019
• 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: Required Intervention