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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 Problem Image Orientation Incorrect (1305)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/03/2018
Event Type  malfunction  
Manufacturer Narrative
No parts have been returned to the manufacturer for analysis.
 
Event Description
Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess). It was reported that the scan was not correctly oriented. The manufacturer representative was unable to rotate the scan 90 degrees anterior/posterior. It was also noted that the 3d model was oriented incorrectly. The surgeon opted to abort navigation as a result. It was determined via phone that the scan was not to protocol and was provided by another site. The procedure was delayed less than one hour, with no impact on patient outcome.
 
Manufacturer Narrative
A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue. Analysis found that the event wasn't caused by a software issue. Analysis found that the software functioned as designed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess). It was reported that the scan wasn't oriented correctly. Rep attempted to rotate 90 degrees anterior/posterior but was unable. Rep noted that the 3d model was also oriented incorrectly due to this. The surgeon opted to abort navigation as a result. Analysis showed the scan was not to protocol. There was no impact to patient. There was a reported delay to the procedure of less than 1 hour due to this issue.
 
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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
erika mitchellette
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7824249
MDR Text Key118532989
Report Number1723170-2018-04266
Device Sequence Number1
Product Code HAW
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,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2018
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
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/21/2017
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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