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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733560XOM
Device Problem Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 11/25/2019
Event Type  malfunction  
Manufacturer Narrative
The unique identifier was not available at the time of reporting. No parts have been received by the manufacturer for evaluation. The manufacture date was not available at the time of reporting. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess). It was reported that the 2d view in navigate was flickering from the ct image to solid black, then back again. Rebooting the system did not resolve the issue. The issue resolved when the emitter was adjusted and the manufacturer representative informed the site that only one instrument can be tracking in the field at a time. There was less than an hour delay in the procedure. No impact on patient outcome.
 
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Brand NameFUSION¿ ENT NAVIGATION SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC
826 coal creek circle
louisville CO 80027
Manufacturer Contact
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key9458914
MDR Text Key188085793
Report Number1723170-2019-05984
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 Other Health Care Professional
Type of Report Initial
Report Date 12/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9733560XOM
Device Catalogue Number9733560XOM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/25/2019
Was Device Evaluated by Manufacturer? No
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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