MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC NAVIGATION STEALTH STATION S8 EM ENT SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9735669

Device Problems Human-Device Interface Problem (2949); Output Problem (3005)

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

Event Date 10/11/2019

Event Type  malfunction  

Manufacturer Narrative

No devices were returned to the manufacturer for analysis.Other relevant device(s) are: product id: 9735521, serial/lot #: unk.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that, while in a product demo for a functional endoscopic sinus surgery (fess), three emitters displayed a red status when tracking instruments.It was later reported that the emitter was raised an additional 3-4 inches away from the bed and tracking could be performed.The site was able to complete the procedure by switching the emitter.There was no reported impact on patient outcome.

• Brand Name: NAVIGATION STEALTH STATION S8 EM ENT 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: 9296729
• MDR Text Key: 178190888
• Report Number: 1723170-2019-05530
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169838918
• UDI-Public: 00643169838918
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9735669
• Device Catalogue Number: 9735669
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/18/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/14/2016
• 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: 62 YR
• Patient Weight: 71