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

Model Number S7

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Unique device identification (udi) unavailable.Device manufacturing date is, therefore, unavailable.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The software investigation found that the reported event was unrelated to a software issue.The universal drill guide (udg) is a calibrated instrument and as a result, you can accidentally verify the instrument outside of the divot causing this behavior.The software functioned as designed.

Event Description

Medtronic received information regarding a navigation device being used outside a procedure.It was reported that while verifying a universal drill guide (udg), it was discovered that the udg would verify at approximately 1cm from the divot.The udg would verify inside the divot just fine, however the udg would consistently pass verification outside of the divot (on both demo spine model and spine air frame).The behavior was repeated on a different udg and other trackers.The instrument would pass no matter how egregious the divot errors they ranged from 4-16mm.The instrument would navigate inaccurately following a successful verification.This was discovered during a spine tray inventory and there was no patient present when this issue was identified.

• 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: heather davis ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7664732
• MDR Text Key: 113266912
• Report Number: 1723170-2018-03163
• Device Sequence Number: 1
• Product Code: HAW
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• 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: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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