MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTHSTATION S7 SYSTEM; EAR, NOSE AND THROAT STEREOTAXIC INSTRUMENT

Model Number 9733856

Device Problem Human-Device Interface Problem (2949)

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

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: other relevant device(s) are: product id: 9660651r, serial/lot #: unknown.Patient weight not available from the site.No parts have been returned to the manufacturer for analysis.Device manufacturing date unavailable.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation device being used for a functional endoscopic sinus surgery (fess).The reported issue occurred pre-operatively.It was reported that the system¿s axiem was in red status and was not communicating in the software.The system was rebooted numerous times without resolution, and the axiem power/communication cable was reseated.The site completed the case using another medtronic navigation system.There was a surgical delay of less than 1 hour due to this issue, and there was no impact on patient outcome.A medtronic representative (rep) later went to the site; the rep connected the emitter to the left port on the axiem box and it functioned normally, but when he connected to the right port it would show that the axiem status was not functioning properly.

Manufacturer Narrative

Other relevant device(s) are: product id: 9660651, serial/lot #: (b)(4.Device evaluation: a medtronic representative went to the site to test the equipment.The axiem was replaced, thus resolving the issue.The navigation system then passed the system checkout and was found to be fully functional.The axiem was returned to medtronic for further evaluation.Upon initial connection to a known good test system, all ports tracked normally when the emitter was connected to lemo port one.After leaving the unit connected for five hours, all ports remained tracking.When the emitter was connected to lemo port two, a red status was displayed for the axiem box, emitter and tool ports.It was determined that there was an electrical failure with the returned axiem.This issue was documented in a medtronic navigation hardware anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S7 SYSTEM
• 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: 8900137
• MDR Text Key: 154550391
• Report Number: 1723170-2019-04496
• Device Sequence Number: 1
• Product Code: PGW
• 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: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 08/16/2019
• Supplement Dates FDA Received: 09/07/2019
• 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: 13 YR