MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8 PREMIUM; INSTRUMENT, STEREOTAXIC

Model Number 9735665

Device Problem Output Problem (3005)

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

Event Date 03/22/2020

Event Type  malfunction  

Manufacturer Narrative

This was reported under a imaging system regulatory report #: 3006544299-2020-00117.No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported outside of a procedure that the midas had intermittent navigation.No patient was present at the time of the event.Additional information was received stating that there was a 10 minute delay in the case.There was no impact on patient outcome.They navigated a gear shift in lieu of the drill.The communication between the imaging system and the navigation system were fine.The midas was not being seen by the camera.Some troubleshooting was done to fix the issue, but in the interest of minimizing delay, and with other tools on the table that navigated accurately, the health care professional moved on.The issue may have been user error or situational.The site used a different instrument to complete the case.

Manufacturer Narrative

Additional information received from a manufacturer representative reported the correct patient information.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information was received from the manufacturing representative that after the case, she had checked out the drill and it navigated without issue.The navigation system performed as intended and passed a system checkout.If information is provided in the future, a supplemental report will be issued.

• Brand Name: S8 PREMIUM
• 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: 10000912
• MDR Text Key: 189339613
• Report Number: 1723170-2020-01301
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169722187
• UDI-Public: 00643169722187
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735665
• Device Catalogue Number: 9735665
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2019
• 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: 60 YR
• Patient Weight: 75