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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM
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MONTERIS MEDICAL NEUROBLATE® SYSTEM Back to Search Results
Model Number 20360
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Codes Edema (1820); Hemorrhage/Blood Loss/Bleeding (1888); Patient Problem/Medical Problem (2688)
Date of Event 12/20/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that following an ablation procedure, the patient experienced cerebral edema and a hemorrhage in the right cerebellum.The patient also experienced injury to the right temporal bone.The patient was treated with a craniotomy and ventriculostomy.The event was considered resolved on (b)(6) 2017.There were no further patient complications reported in relation to this event.
 
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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 Key8182596
Report Number3009970070-2018-00092
Device Sequence Number13727782
Product Code GEX
UDI-Device Identifier00816589020656
UDI-Public00816589020656
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K173305
Number of Events Summarized1
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) 12/19/2018
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 Number20360
Device Catalogue NumberNB102
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/20/2018
Initial Report FDA Received Date12/19/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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