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

Model Number 9735736

Device Problem Human-Device Interface Problem (2949)

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 fess procedure.The manufacturer representative (rep) indicated they were having difficulties registering.With the patient tracker turned on they were getting around 5.9 and the rep indicated that they ensured they followed a good trace pattern with green dots.After removing the patient tracker a re-trace was done and it dropped to 1.3.The delay in surgery was less than one hour and there was no impact or change in 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 log analysis.Analysis found that insufficient information to determine why there was a difference in registration metrics with cad initialization and without." 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 equipment.Testing revealed that all components passed checkout.The system then passed the system checkout and was found to be fully functional.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the manufacturer representative (rep) who indicated that they were able to register the blue demo head with and without the tracker being turned on.When the tracker was on the rep got a 0.8 and with the tracker being off the rep got a 0.9, however the archive was no longer available at the time the rep was on site as the data had been deleted.

• Brand Name: STEALTH 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: 8159794
• MDR Text Key: 130348089
• Report Number: 1723170-2018-06232
• 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
• 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