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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 Erratic or Intermittent Display (1182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2018
Event Type  malfunction  
Manufacturer Narrative
A representative was at the site. It was found that there was a loose cable connection on the back of the monitor. Tightening the cable resolved the issue. Part not returned.
 
Event Description
Medtronic received information that while using the navigation system for a functional endoscopic sinus surgery (fess), the screen went completely black, followed by having black lines across the screen. Enough of the screen was visible that the site was able to continue with the case. There was no reported delay to the procedure 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
parker desautel
navigation customer quality
826 coal creek circle
louisville, CO 80027
MDR Report Key7873108
MDR Text Key120154400
Report Number1723170-2018-04632
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,health
Reporter Occupation
Type of Report Initial
Report Date 09/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFUSION
Device Catalogue Number9733560
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 Received08/22/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2016
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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