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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) FUSION NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number FUSION
Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/05/2017
Event Type  malfunction  
Manufacturer Narrative
Reporting rn declined to provide patient weight. On 04/06/2017 a medtronic representative, following-up at the site, confirmed being unable to replicate the behavior. The medtronic representative re-seated all of the connections. On 04/07/2017 a medtronic representative performed a navigation system check-out, all areas passed. System performed as intended. No parts were replaced. No parts have been received by manufacturer for analysis. No further issues have been reported.
 
Event Description
A site registered nurse (rn) / operating room (or) director, reported that while in a functional endoscopic sinus surgery (fess), their navigation system's monitor displayed the message 'no input detected' within the navigation screen. The site attempted to re-boot the navigation system without resolution. A second navigation system was brought in to continue the procedure. There were no further issues. The surgeon opted to continue and completed the procedure with the use of the navigation system. Delay in therapy was 20 minutes. There was no impact on patient outcome.
 
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Brand NameFUSION NAVIGATION SYSTEM
Type of DeviceNEUROLOGICAL 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
judith ericson
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6542921
MDR Text Key74367464
Report Number1723170-2017-01799
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994380005
UDI-Public00613994380005
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K001284
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 05/03/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/03/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560XOM
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 Received04/05/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2011
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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