• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

  • 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
 

MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number TREON
Device Problem No Display/Image (1183)
Patient Problems No Consequences Or Impact To Patient (2199); Therapeutic Response, Decreased (2271)
Event Date 02/21/2018
Event Type  Injury  
Manufacturer Narrative
Patient information was unavailable from the site. Device udi not provided as this product is no longer manufactured. A medtronic representative went to site to test the equipment. The monitor did not show picture on the screen. Representative reported that a monitor was replaced to resolve the issue. A system checkout was performed and the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The suspect computer has not been received by the manufacturer for evaluation.
 
Event Description
A site representative reported that during cranial resection, the navigation system was not booting up and no signal on the screen. It was reported that the monitor remained on black screen and the surgeon was unable to start the software application and the application. The surgery was rescheduled. The delay was less than 1 hour. No impact on patient outcome.
 
Manufacturer Narrative
Correction: udi number field updated with the correct information; device manufacturing date is updated with the correct information.
 
Manufacturer Narrative
The monitor was returned to the manufacturer for analysis. Analysis found that the monitor had a blank display when connected to a known good system. Analysis found that the reported event was related to a electrical issue. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
Manufacturer Narrative
Correction: additional review of the reported issue found that aborting the procedure while the patient was under anesthesia is considered an adverse event. Subsequent fields have been updated.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSTEALTHSTATION TREON TREATMENT GUIDANCE SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7341996
MDR Text Key102505069
Report Number1723170-2018-01145
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 07/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTREON
Device Catalogue Number9680111
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2007
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/15/2018 Patient Sequence Number: 1
-
-