• 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) FUSION NAVIGATION 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) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number FUSION
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 05/02/2018
Event Type  malfunction  
Manufacturer Narrative
Udi not available for this system at time of filing. Device manufacturing date is unavailable. A medtronic representative went to the site to test the equipment. The representative found the computer would reboot spontaneously. They replaced the box and the multi-out power supply. The navigation system then passed the system checkout and was found to be fully functional. The suspect integrated port, power supply enclosure assembly, field generator, fan, and internal cable were returned for evaluation. Analysis could not replicate the issue and there were no issues found. The suspect computer was returned for evaluation. Analysis confirmed the reported problem. After exiting the ear, nose & throat (ent) application, the display was black. Repeated rebooting, reseating modules and cards did not resolve the issue. The suspected issue is within the motherboard. A computer failure was confirmed.
 
Event Description
Medtronic received information regarding a navigation device being used outside a procedure. It was reported that the system was booting inconsistently, sometimes only booting the monitor or booting fully then shutting itself down. The system was used for a clinical case, but there was no patient involvement. Additional information received reported during troubleshooting, they changed the port the computer was plugged into on the isolation transformer. The site rebooted the system multiple times and entered different parts of the software, including admin screen, with no replication of the issue. They were going to the leave the system running inside the ear, nose & throat (ent) software for the next cases at the account and check back every 15 minutes or so. The following day, after switching the power position on the isolation transformer, they rebooted the system and left it on the select patient screen. After about 30 minutes, when the system was checked on, it had exited the software on its own. The representative on site tried to bypass the isolation transformer and connect the computer directly into the wall outlet, with no resolution. Further troubleshooting found that when only the mouse, monitor, and keyboard were plugged in, the system functioned normally. When the navigation box was connected, the issue reoccurred. The system speakers were noted to not be working, too. The box would be replaced.
 
Manufacturer Narrative
Additional information: unique device identification (udi) and device manufacture date provided. Correction: product and related fields updated to proper value.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFUSION NAVIGATION 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
MDR Report Key7556975
MDR Text Key109742835
Report Number1723170-2018-02326
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 07/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/05/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-