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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT

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MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Model Number S7
Device Problems No Display/Image (1183); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)
Patient Problem No Patient Involvement (2645)
Event Date 04/05/2017
Event Type  malfunction  
Manufacturer Narrative
No patient information provided as no patient was involved in this concern. Return requested. Replacement 4port vga splitter and multiout 350w power supply both shipped to site 04/05/2017. No parts have been received by manufacturer for analysis. -on 04/11/2017 a medtronic representative performed a navigation system check-out, all areas passed. System performed as intended. - replaced vga splitter and uninterruptible power supply (ups). - no further issues have been reported.
 
Event Description
A site representative reported that their navigation system monitors, staff and surgeon, were flickering and rendered usable intermittently. Monitor image was compressed to a line at top of the screen, perhaps a fifth or a fourth. No further details regarding the behavior, or specifically when it occurred, were provided. There was no patient present when this issue was identified.
 
Manufacturer Narrative
The suspect vga splitter was returned to the manufacturer for analysis. The splitter was found to be fully functional with no problem found. The reported event could not be duplicated by medtronic personnel. The suspect power supply was returned to the manufacturer for evaluation. Testing found physical damages from the 9vac plug being inserted into the housing of the power supply. The unit passed functional testing. The hardware investigation found that the reported event was related to a hardware issue. This issue was documented in a medtronic navigation hardware anomaly tracking database.
 
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Brand NameSTEALTHSTATION S7 SYSTEM
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer (Section G)
MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
826 coal creek circle
louisville CO 80027
Manufacturer Contact
peter verhey
attn:product quality experienc
826 coal creek circle
louisville, CO 80027-9710
7208902187
MDR Report Key6532998
MDR Text Key74039604
Report Number1723170-2017-01795
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450968
UDI-Public00613994450968
Combination Product (y/n)N
Reporter Country CodeSE
PMA/PMN Number
K050438
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/16/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733858
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/09/2013
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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