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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTH S8 EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC STEALTH S8 EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT Back to Search Results
Model Number 9735736
Device Problem Human-Device Interface Problem (2949)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/06/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information from a manufacturer representative (rep) regarding a navigation system being used for a fess procedure. The manufacturer representative (rep) indicated they were having difficulties registering. With the patient tracker turned on they were getting around 5. 9 and the rep indicated that they ensured they followed a good trace pattern with green dots. After removing the patient tracker a re-trace was done and it dropped to 1. 3. The delay in surgery was less than one hour and there was no impact or change in patient outcome. There were no further complication reported or anticipated.
 
Manufacturer Narrative
A software analysis was initiated to determine the probable cause of the issue through log analysis. Analysis found that insufficient information to determine why there was a difference in registration metrics with cad initialization and without. " if information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A medtronic representative went to the site to test the equipment. Testing revealed that all components passed checkout. The system then passed the system checkout and was found to be fully functional. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep) who indicated that they were able to register the blue demo head with and without the tracker being turned on. When the tracker was on the rep got a 0. 8 and with the tracker being off the rep got a 0. 9, however the archive was no longer available at the time the rep was on site as the data had been deleted.
 
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Brand NameSTEALTH S8
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
stacy ruemping
7000 central avenue ne rcw215
minneapolis, MN 55432
7635260594
MDR Report Key8159794
MDR Text Key130348089
Report Number1723170-2018-06232
Device Sequence Number1
Product Code PGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/13/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735736
Device Catalogue Number9735736
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/24/2019
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 Unkown

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