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

Model Number 9736242

Device Problem Application Program Freezes, Becomes Nonfunctional (4031)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 9 736226, serial/lot #: (b)(4), udi#: (b)(4).Software analysis determined the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system being used outside of a procedure.It was reported that the system could not start up.On power up, login to the system was performed normally.After this, a black screen with the manufacturer logo appeared (normal splash screen), but then nothing happened¿afterwards.During normal operation, the software application options would appear (ex: "ent," "spine," or "cranial"), but nothing appeared.The system was powered down and restarted with the same result.The startup procedure only advanced to the black screen.System functionality was restored upon system restart after powering down the system and disconnecting all peripheral devices (electromagnetic emitter interface box, emitter and mouse).There peripheral devices were reconnected and the surgery was then performed.The reported issue occurred pre-operatively with no patient present.It was noted the issue happened before, but did not happen every time.It seemed that if the system worked well once, and nothing is disconnected, then it would work the next time.If devices were disconnected and re-connected, it seemed that this error was possible.

• Brand Name: STEALTHSTATION FLEXENT
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12333689
• MDR Text Key: 266974890
• Report Number: 1723170-2021-02099
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K200723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9736242
• Device Catalogue Number: 9736242
• Device Lot Number: 0010351045
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2020
• 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