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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 Problem Poor Quality Image (1408)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/05/2016
Event Type  malfunction  
Manufacturer Narrative
Patient weight not available from the site. Issue was recreated in the technical services (ts) lab. Adjusting the overrides settings did not help the image. The scan was taken in a bone algorithm. It was recommended that the radiology department reconstruct in a soft-tissue algorithm then load the scan onto the navigation system. The software investigation found that the reported event was unrelated to a software issue. The software functioned as designed. Symptom resolved by updating overrides lines to the software. No parts were replaced. 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 spinal fusion procedure, the computed tomography (ct) image for a spine point-merge procedure loaded very pixelated in the navigation system. Threshold and adjusting the contrast did not resolve the image issue. To troubleshoot, the medtronic representative added the media io overrides lines to the spine application: truncatenegativectpixels: true constantctpixeloffset: 1024. Resetpixelrange: false. Maxctpixelvalue: 4095. The image loaded better after adding the overrides lines to the software. While the medtronic representative was troubleshooting, the surgeon opted to continue and to complete the procedure without the use of the navigation system because the anatomy was too hard to make out in the exam and was unable to perform a pointmerge registration. There was a reported delay to the procedure of less than 1 hour due to this issue. There was no impact on patient outcome.
 
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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
MDR Report Key6209101
MDR Text Key63622972
Report Number1723170-2016-05945
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,health
Reporter Occupation Medical Equipment Company Technician/Representative
Type of Report Initial
Report Date 12/28/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/28/2016
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 Received12/05/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/28/2013
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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