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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 Device Stops Intermittently (1599); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 11/30/2017
Event Type  malfunction  
Manufacturer Narrative
Product and associated fields updated to proper value. The interface box for the navigation system was returned to the manufacturer for analysis. The device was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that hardware did not pass testing and the axiem was replaced. The system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Device lot number, or serial number, unavailable. Device manufacturing date is dependent on lot number/serial number, therefore, unavailable. No parts have been returned to the manufacturer for evaluation.
 
Event Description
A medtronic representative reported that while outside of a procedure, the axiem ® box was functioning intermittently on the navigation system and was displaying an 8 in the controller status. 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
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7635267745
MDR Report Key7151108
MDR Text Key103059227
Report Number1723170-2017-05314
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,health
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 02/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2017
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 Received01/16/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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