Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MONTERIS MEDICAL NEUROBLATE® SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MONTERIS MEDICAL NEUROBLATE® SYSTEM Back to Search Results
Model Number 20360
Medical Device Problem Code No Apparent Adverse Event (3189)
Health Effect - Clinical Codes Hemorrhage/Blood Loss/Bleeding (1888); Neurological Deficit/Dysfunction (1982); Thrombosis (2100); Weakness (2145)
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Summary of events: 6 patients experienced neurological deficit; 20 patients experienced bleeding; 1 patient experienced a deep vein thrombosis; 4 patients experienced permanent weakness.
 
Event or Problem Description
It was reported that following an ablation procedure, multiple patients "experiences" neurological deficits (4 worsening pre-motor, 1 new upper extremity weakness, and 1 hemiparesis), 20 experienced bleeding which were treated conservatively, 1 experienced a deep vein thrombosis, and 4 experienced permanent weakness which did not improve with follow-up.There were no further patient complications reported in relation to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8196384
Report Number3009970070-2018-00093
Device Sequence Number1630695
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,litera
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/26/2018
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 11/26/2018
Initial Report FDA Received Date12/26/2018
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;
-
-