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

Model Number S7

Device Problem Imprecision (1307)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Onsite investigation was preformed and the field systems engineer was unable to replicate the reported event.System functioned as designed and without issues.He noted that the inaccuracy was noticed more superficially and as they proceeded in the sinus the accuracy got better.The scan they were using was taken approximately 40 days prior to the procedure.A full system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A site representative reported that, while in a functional endoscopic sinus surgery, the surgeon felt accurate on the nose, but then when using the navigated blade, felt inaccurate.The surgeon went back to the tracer probe and was inaccurate again.They re-registered, and this time some of the tracer points were collected superior to anatomy that was actually included in the scan; the scan was missing the forehead, and they were still inaccurate on the tip-of-the nose by about 2-3 cm.The case was continued with the use of navigation.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no impact on patient outcome.

Manufacturer Narrative

A medtronic representative, following up with the site, reported that there have been no additional occurrences since this event.The software investigation was unable to determine the probable cause without further information.However it is suspect that the issue was compounded by possible poor tracer pattern and the use of an older scan.The instructions for use (ifu) that accompanies the device provides guidance for multiple registration methods.

• 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: kristianna bilan ; 826 coal creek circle; louisville, CO 80027 ; 7208902338
• MDR Report Key: 6194237
• MDR Text Key: 62968245
• Report Number: 1723170-2016-05847
• 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,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Yes
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/21/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2008
• 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: 54 YR
• Patient Weight: 71