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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 Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 02/27/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Device manufacturing date is unavailable. A medtronic representative went to site to test the equipment. Representative reported that a computer and computer case were replaced to resolve the issue. A system checkout was performed and the hardware, software, and instruments passed the system checkout. The system was found to be fully functional. The suspect parts have not been received by the manufacturer for evaluation.
 
Event Description
A site representative reported that while outside of procedure, the navigation system became unresponsive when connected to endoscope during navigation. It was reported that system was working as expected without the video feed. There was no patient present at the time of the issue.
 
Manufacturer Narrative
Additional information: device manufacture date provided. Correction: unique device identification (udi) updated to proper value.
 
Manufacturer Narrative
Correction: the computer case for the navigation system was returned to the manufacturer unused, indicating that the component was not replaced.
 
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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
peter verhey
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7361730
MDR Text Key103175822
Report Number1723170-2018-01226
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
PMA/PMN Number
K153247
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/22/2018
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? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/21/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/26/2017
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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