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

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.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL 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 Key: 6209101
• MDR Text Key: 63622972
• Report Number: 1723170-2016-05945
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR