• 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 Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 05/11/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. It was unable to duplicate the issue; however, the system failed the hardware checkout but passed the software and instrument checkout. The emitter was replaced, and system performed as intended. The imaging system then passed the system checkout and was found to be fully functional. No parts have been returned to the manufacturer for evaluation.
 
Event Description
Medtronic received information regarding a navigation device being used outside of procedure. It was reported that when trying to track the instrument tracker it will flicker in and out while moving it slowly a fists distance from the emitter. When the patient tracker moves the same thing occurs.
 
Manufacturer Narrative
The field generator was returned to the manufacturer for analysis. The unit was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
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 Key7582903
MDR Text Key110512046
Report Number1723170-2018-02612
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 07/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/08/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560XOM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/20/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/11/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-