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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 ENT STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC S8 ENT STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735669
Device Problem Output Problem (3005)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/13/2020
Event Type  malfunction  
Manufacturer Narrative
Patient information not provided due to canadian patient privacy regulations. No parts have been received by the manufacturer for evaluation. Other relevant device(s) are: product id: 9735736, serial/lot #: unk. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that, while in a functional endoscopic sinus surgery (fess), the 2d images on the navigation system would intermittently increase in size (consistent with zooming) without prompt from the user. It was reported that the issue occurred during navigation and that exiting and re-entering the procedure restored functionality. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no reported impact on patient outcome.
 
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Brand NameS8 ENT STEALTHSTATION 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 Key9586192
MDR Text Key175394171
Report Number1723170-2020-00136
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K162309
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735669
Device Catalogue Number9735669
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 Received04/22/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2018
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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