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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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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); Device Stops Intermittently (1599)
Patient Problem No Patient Involvement (2645)
Event Date 12/20/2017
Event Type  malfunction  
Manufacturer Narrative
Correction: device manufacture date updated to proper value. While testing the navigation system, it was reported that the computer for the navigation system was replaced. The computer for the navigation system was returned to the manufacturer for analysis. The device was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to site to test the equipment. Representative was able to replicate the reported issue with multiple patient exams and confirmed that other system were functioning without issue. No information regarding resolution has been provided. No parts were replaced. No parts have been received by the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that while outside of procedure, the navigation system would intermittently become unresponsive and had to be rebooted manually. Uninstalling and reinstalling the software did not resolve the issue. There was no patient present at the time of the issue.
 
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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
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7204040
MDR Text Key103083648
Report Number1723170-2018-00292
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,user f
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup
Report Date 02/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/18/2018
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 Manufacturer01/19/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/30/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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