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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S7 STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC

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MEDTRONIC NAVIGATION, INC S7 STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC Back to Search Results
Model Number 9733856
Device Problems Display or Visual Feedback Problem (1184); Output Problem (3005)
Patient Problem No Patient Involvement (2645)
Event Date 03/23/2020
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. Testing revealed that the computer of the navigation system was replaced to restore functionality. The system then passed the system checkout and was found to be fully functional. The computer for the navigation system was returned to the manufacturer for evaluation. However, results are not available at the time of filing. Other relevant device(s) are: product id: 9734477, serial/lot #: (b)(4), ubd: 31-jan-2017. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information regarding a navigation system being used outside of a procedure. It was reported that while loading exams, both the monitors went black. The site also reported green flickering lines at the top of the monitor. The site used a different navigation system for an upcoming case. There was no patient present when this issue was discovered.
 
Manufacturer Narrative
The computer was returned to the manufacturer for analysis. The computer was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameS7 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 Key9953261
MDR Text Key187405776
Report Number1723170-2020-01209
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 05/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/19/2012
Device Model Number9733856
Device Catalogue Number9733856
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/04/2011
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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