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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC FUSION COMPACT EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735602
Device Problem Environmental Compatibility Problem (2929)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/29/2020
Event Type  malfunction  
Manufacturer Narrative
Patient information was unavailable from the site. No devices were returned to the manufacturer for analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used intra/peri-operatively of a functional endoscopic sinus surgery (fess) procedure. It was reported that the power suddenly went off while reading the data. The system worked normally after restarting. There was no delay in the procedure and no impact on patient outcome.
 
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Brand NameFUSION COMPACT
Type of DeviceEAR, 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
tricha miles
7000 central avenue ne rcw215
minneapolis, MN 55432
7635140379
MDR Report Key10727593
MDR Text Key212841969
Report Number1723170-2020-02784
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K153247
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735602
Device Catalogue Number9735602
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 Received10/25/2020
Was Device Evaluated by Manufacturer? No
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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