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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC FUSION¿ ENT NAVIGATION SYSTEM; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9733560XOM
Device Problem Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/17/2018
Event Type  malfunction  
Manufacturer Narrative
Device serial number unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that the system was performing as intended.The system passed the system checkout and was found to be fully functional.No parts on the system were replaced.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 site had a red status on the patient tracker, and the patient tracker was unable to be used.The site swapped for another patient tracker and the issue was resolved.The site disposed of the patient tracker that wasn't working.This issue was observed intraoperatively.There was a surgical delay of 5 minutes, and there was no impact on patient outcome.A medtronic representative noted that this issue had not occurred again in a clinical case since the day of the reported event.
 
Manufacturer Narrative
Additional information: a software investigation analysis was initiated to determine the probable cause of the issue through log analysis.Analysis found that hardware issue is suspected since the issue was resolved by swapping patient tracker.Analysis found that the analysis was inconclusive and probable cause was unable to be determined.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
FUSION¿ ENT NAVIGATION SYSTEM
Type of Device
EAR, 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 Key8246765
MDR Text Key133071504
Report Number1723170-2019-00246
Device Sequence Number1
Product Code PGW
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 04/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number9733560XOM
Device Catalogue Number9733560XOM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/17/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age33 YR
Patient Weight79
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