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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) MEDTRONIC FUSION COMPACT NAVIGATION SYSTEM EAR NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number FUSION COMPACT
Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Displays Incorrect Message (2591)
Patient Problem No Patient Involvement (2645)
Event Date 06/09/2017
Event Type  malfunction  
Manufacturer Narrative
Later the same day another medtronic representative attempted to load the disk on the system. They were also unsuccessful. The error message would go away after pressing cancel, but return shortly after. This happened about 5-6 times. When the option to report problem was selected, the prompt for a password would show up. A replacement computer was sent to the site for issue resolution. On 6/26/2017 the medtronic rep reported that they were able to load the ent tools 7 on the compact and could not replicate the issue they were having before. All instruments performed without issue after tools cd was installed. Computer that was shipped was unopened and will be returned unused.
 
Event Description
A medtronic clinical specialist reported that when trying to load the tools 7 disk in the fusion compact t he system becomes unresponsive. She tried again while on the call, but the screen stated "system problem detected," and prompted her for a password. The screen went blank and the system rebooted itself. No patient present.
 
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Brand NameMEDTRONIC FUSION COMPACT NAVIGATION SYSTEM
Type of DeviceEAR NOSE AND THROAT 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
catherine eaton
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902092
MDR Report Key6692150
MDR Text Key79249719
Report Number1723170-2017-02831
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153247
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
Report Date 07/06/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION COMPACT
Device Catalogue Number9735602
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/09/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/07/2016
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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