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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 Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 05/14/2018
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. No investigation was performed as the issue was resolved at the time of the event.
 
Event Description
Medtronic received information that a communication error occured between the computer and the axiem box. The error was suggesting power cycling the system. The system was rebooted which resolved the issue. There was no patient present when this issue was identified.
 
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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
prashanth gali
navigation customer quality
826 coal creek circle
louisville, CO 80027-9710
7208902515
MDR Report Key7587192
MDR Text Key110632182
Report Number1723170-2018-02651
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 06/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2018
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2016
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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