MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S8 EM ENT SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Catalog Number 9735669

Device Problems Computer Software Problem (1112); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative was able to replicate the reported issue.The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.

Event Description

Medtronic received information regarding a navigation system.It was reported outside of a procedure that when the site was using the 90-degree suction the icon that appeared was for the 90-degree curette.There was no patient present at the time of the issue.

• Brand Name: STEALTHSTATION S8 EM ENT SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: prashanth gali ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7658711
• MDR Text Key: 113027634
• Report Number: 1723170-2018-03104
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 07/03/2018

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: Physician
• Device Catalogue Number: 9735669
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2017
• 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