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

Catalog Number 9735665

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Patient Involvement (2645)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to the site to test the equipment.Testing revealed that the camera cart displayed no input and that the green power led was illuminated and that the camera was communicating.Reseating the hard drive of the computer of the navigation system restored functionality.The system then passed the system checkout and was found to be fully functional.No parts were replaced, therefore no parts were returned for analysis.

Event Description

Medtronic received information that, while outside of a procedure, the navigation system became unresponsive without prompt from the user.There was no patient present when this issue was identified.No additional information was provided.

Manufacturer Narrative

Correction: udi and manufacture date provided.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTHSTATION S8 PREMIUM 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7615596
• MDR Text Key: 111669208
• Report Number: 1723170-2018-02875
• Device Sequence Number: 1
• Product Code: HAW
• 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,Followup
• Report Date: 01/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9735665
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2017
• 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