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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735602
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Patient Involvement (2645)
Event Date 11/19/2018
Event Type  malfunction  
Manufacturer Narrative
Site declined a system checkout as the issue was resolved on the technical services (ts) call and has not recurred. Device manufacturing date unavailable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported there were issue with the connection between the navigation system and the axiem and the site had to boot the system three times to establish a connection. It was noted on the first boot, the axiem was booted first and the site waited several minutes before the navigation system was booted, and there was no connection. For the second boot, the axiem was booted, and it was more than 10 minutes before the navigation system booted. On the third boot, a connection was established. It was noted the system was used again that same day with no issue. This issue was noted outside of a procedure, and there was no patient involvement.
 
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Brand NameFUSION COMPACT
Type of DeviceEAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
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 Key8166069
MDR Text Key130468762
Report Number1723170-2018-06284
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeFI
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/14/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735602
Device Catalogue Number9735602
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 Received11/19/2018
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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