MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC S8; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9735736

Device Problem Computer Software Problem (1112)

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

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a manufacturer representative (rep) regarding a navigation system being used for a procedure.The rep reported that during the registration task when they tried to place the patient reference frame on the side of the patient model it was consistently floating above the registration model instead of sitting on the skin.The rep adjusted the 3d model to clean it up and it still occurred.The only place that the issue did not occur was high above the right eye and the rep noted that this issue had happened in every clinical case so far.There was a patient involved with the issue, but there was no impact or change to patient outcome.There were no further complication reported or anticipated.

Manufacturer Narrative

A software analysis was initiated to determine the probable cause of the issue through design analysis.Analysis found that the behavior described is the intended behavior of the software.Software is functioning as designed.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A medtronic representative went to the site to test the navigation system.The system was passed all test and was found to be fully functional.No parts required replacement.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Follow-up with manufacturer reps determined that the system would fail to boot up, but the two times it occurred they were able to type in lines with unburnt and replacement of the defective hard drive.The rep then indicated the site now traces without the reference frame and the floating was about 4 mm off the model.The surgical delay was reported as about 5 minutes.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received which indicated that the issue occurred during a fess procedure.The rep indicated that from the log files on the day of the case and the rep was able to see that on the demo model the patient tracker was hovering above the skin model on the registration page.However, the rep was able to successfully register the model with no issues.The rep did not know if there was any change in patient outcome or delay in surgery.

• Brand Name: S8
• Type of Device: EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT
• 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: 8159496
• MDR Text Key: 130266719
• Report Number: 1723170-2018-06230
• Device Sequence Number: 1
• Product Code: PGW
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735736
• Device Catalogue Number: 9735736
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Weight: 73