MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S7 SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733856

Device Problem Human-Device Interface Problem (2949)

Patient Problems No Known Impact Or Consequence To Patient (2692); Radiation Exposure, Unintended (3164)

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.Testing revealed that the issue could not be replicated.The system then passed the system checkout and was found to be fully functional.Device manufacturing date is unavailable.Other relevant device(s) are: 9733686 synergy spine software.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used intra/peri-operatively of a sacroiliac and thoracolumbar procedure.It was reported that the site's second spin had failed to transfer.The site took one spin, navigated without issue, and when they took the second spin, it wouldn't automatically transfer.They were unable to manually transfer either.The site was able to complete the procedure with the first spin and the 2nd spin was not required.There was a less than 1-hour delay to the procedure and no impact on patient outcome.

Manufacturer Narrative

The logs for the navigation system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NAVIGATION STEALTH STATION S7 SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 8983879
• MDR Text Key: 157363757
• Report Number: 1723170-2019-04831
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733856
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2019
• 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
• Patient Age: 61 YR
• Patient Weight: 112