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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 Device Stops Intermittently (1599); Communication or Transmission Problem (2896)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/03/2016
Event Type  malfunction  
Manufacturer Narrative
In trouble-shooting, the medtronic representative left the navigation system on overnight to keep it in the state it was during the procedure. Upon check-out, observed the same behavior where the passive planar would track normally, but the gold teratracker with universal drill guide (udg) would not track or verify. Returned to "verify instruments" task and confirmed the toolcard was there. Then moved forward back into navigate and the tracker could be seen and verified. On 11/04/2016 a medtronic representative performed a navigation system check-out, all areas passed. System performed as intended. On 11/30/2016 a medtronic representative, following-up at the site, reported the issue appeared to be software related. When in the software from navigate to the instruments screen, the navigation system recognized the instrument both there and in the navigate screen, as well. This occurred while navigating, after registration. Used the udg on some levels, using a ct-based registration. Went through a second ct registration successfully, back to navigate the other levels and the udg was no longer recognized by the system. - software investigation has not been completed. - return requested for suspect gold teratracker tracker. No parts have been received by manufacturer for analysis. - no further issues have been reported.
 
Event Description
A medtronic representative reported that, while in a spine procedure, the site's navigation system camera was not tracking the universal drill guide with their gold teratracker after the surgeon moved the reference frame and re-registered the patient. The camera was seeing the same instrument previously when the surgeon was using the opposite side of the spine for two levels. Cleaning spheres, changing or re-seating did not resolve the issue. Geometry was 0. 18. Tracking view was seeing reference frame, but no indication of instrument. Instrument indication on the bottom of the screen never showed the instrument name. The surgeon used the passive planar sharp to line up the starting point and trajectory for the screws, and also had fluoro available. The surgeon opted to continue and completed the procedure with the use of the navigation system. Delay in therapy was less than one hour. There was no impact on patient outcome.
 
Manufacturer Narrative
Log files from the system were analyzed, but did not provide insight into the root cause of the problem. Unable to determine cause of event with available information. No additional similar subsequent issues with this system have been reported to date.
 
Manufacturer Narrative
Correction to device manufacture date now provided.
 
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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
oksana ditolla
826 coal creek circle
louisville, CO 80027-9710
7208902092
MDR Report Key6137065
MDR Text Key61206431
Report Number1723170-2016-05610
Device Sequence Number1
Product Code HAW
UDI-Device Identifier00613994450944
UDI-Public00613994450944
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,foreig
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial,Followup,Followup
Report Date 03/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberS7
Device Catalogue Number9733856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/18/2013
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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