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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 Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/22/2018
Event Type  malfunction  
Manufacturer Narrative
Udi and device manufacture date not available at the time of this report. A medtronic representative went to the site to test the equipment. The rep gathered logs and patient archive. The rep was unable to replicate the reported event. The hardware, software, and instruments passed the system checkout. The system was found to be fully functional.
 
Event Description
A site representative reported via a manufacturer representative that the navigation system unexpectedly exited during the middle of a functional endoscopic sinus surgery (fess) procedure. The system was rebooted and required the surgeon to re-register the patient. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no reported impact to the outcome of the patient.
 
Manufacturer Narrative
Additional information: udi number and device manufacture date have been received and the fields updated with the new information. The software investigation found that the reported event was related to a software issue. This issue was documented in a software anomaly tracking database.
 
Manufacturer Narrative
The power supply for the monitor of the navigation system was returned to the manufacturer for analysis. The power supply was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. The monitor for the navigation system was returned to the manufacturer for analysis. The monitor was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
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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
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7405729
MDR Text Key104821267
Report Number1723170-2018-01515
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,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2018
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 Manufacturer06/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2010
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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