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U.S. Department of Health and Human Services

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

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MEDTRONIC NAVIGATION, INC STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9735894
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 12/06/2019
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. A medtronic representative went to the site to test the equipment. Hardware parts were replaced. A system checkout was performed and the system was working as intended. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system. It was reported outside of a procedure that the monitor was flickering and that rebooting the system did not resolve the issue. It was noted that while flickering mouse movement made the system flicker more. A clinical specialist (cs) checked to make sure all the connections were fully seated. The flickering appeared with lines across the screen and it was noted that the issue occurred during a site training. There was no patient involvement.
 
Manufacturer Narrative
The cable was returned for analysis and no failure was found and the device worked as intended. Codes are associated with the product analysis for the returned cable, codes are associated with the non-return of the monitor, which is currently on back order. It was stated that when the monitor was replaced on the system that it resolved the issue. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSTEALTHSTATION S8 PREMIUM 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 Key9454674
MDR Text Key184738062
Report Number1723170-2019-05974
Device Sequence Number1
Product Code HAW
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 Non-Healthcare Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 03/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number9735894
Device Catalogue Number9735894
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2020
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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