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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC STEALTHSTATION FLEXENT EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9736242
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Application Program Freezes, Becomes Nonfunctional (4031)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/02/2021
Event Type  malfunction  
Manufacturer Narrative
Onsite functional and visual examination was performed by a manufacturer representative. The system passed a system checkout and was determined to be operational. The ssd was returned for analysis. It was determined that the ssd was malfunctioning causing the reported event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation device being used outside of a procedure. It was reported that the localizer faulted. The emitter was disconnected and reconnected, same with emitter. Rebooted and system stayed at medtronic further together. Unplugged components again and system is still stuck on splash screen. There was no patient present when this issue occurred.
 
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Brand NameSTEALTHSTATION FLEXENT
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12211295
MDR Text Key262936048
Report Number1723170-2021-01895
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K200723
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9736242
Device Catalogue Number9736242
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Yes
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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