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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733560XOM
Device Problem Audible Prompt/Feedback Problem (4020)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/04/2019
Event Type  malfunction  
Manufacturer Narrative
Other relevant device(s) are: product id: 9733408, serial/lot #: (b)(4). The manufacturer representative went to the site to test the navigation system. The reported issue was confirmed and parts were replaced. The changed the speaker. Then they checked the sound via root system sound test there was no sound from the speaker. They also changed the i/o hub. The speaker cable was returned to the manufacture for evaluation. After functional testing and visual/physical examination the reported issue was confirmed. The returned speaker assembly had intermittent function when connected to a known good system. The speaker cable had a loose contact that was easily pushed back into the connector allowing only intermittent contact. The i/o hub was returned to the manufacture for evaluation. After functional testing and proceduralized device testing the reported issue was not confirmed. The returned i/o hub was found to be fully functional having passed the functional test with no failures. No problem found. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess). It was reported that there was intermittent sound coming from the system. A patient was present and there was no delay to the case. The manufacturer representative was able to reproduce the issue, and technical services had them check the functionality of the i/o hub. There was no issue with the i/o hub.
 
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Brand NameFUSION¿ ENT NAVIGATION SYSTEM
Type of DeviceINSTRUMENT, STEREOTAXIC
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 Key9531914
MDR Text Key187411292
Report Number1723170-2019-06219
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 Other Health Care Professional
Type of Report Initial
Report Date 12/30/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2018
Device Model Number9733560XOM
Device Catalogue Number9733560XOM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/25/2011
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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