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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONTERIS MEDICAL CORPORATION NEUROBLATE® SYSTEM
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MONTERIS MEDICAL CORPORATION NEUROBLATE® SYSTEM Back to Search Results
Model Number 20360
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Neurological Deficit/Dysfunction (1982); Seizures (2063); Weakness (2145)
Date of Event 08/22/2017
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that following an ablation procedure, the patient experienced an inability to walk but was not immobile, and was discharged from the hospital to a rehabilitation facility on (b)(6) 2017.The patient was then readmitted to the hospital on (b)(6) 2017 for seizure activity with associated weakness, and was prescribed anticonvulsants.The patient was discharged from the hospital from (b)(6) 2017.At discharge, the patient had worsening symptoms of weakness, and speech/aphasia.The event resolution was unknown.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.
 
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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 Key6866392
Report Number3009970070-2017-00149
Device Sequence Number656729
Product Code GEX
UDI-Device Identifier00816589020403
UDI-Public00816589020403
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
K162762
Number of Events Summarized1
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) 09/14/2017
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 Number20360
Device Catalogue NumberNB102
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 09/12/2017
Supplement Date Received by Manufacturer04/30/2018
Initial Report FDA Received Date09/14/2017
Supplement Report FDA Received Date05/29/2018
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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