MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT

Model Number S7

Device Problems Computer Software Problem (1112); Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2018

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative reported that creating a new procedure didn't resolve the issue.The loaded another patient and was able to get to plan without issue.Then they deleted and reloaded the patient and was able to get a plan.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Event Description

Medtronic received information regarding a navigation system outside of a procedure.It was reported that the cranial application was rebooting itself when going from the 'verify instrument' task to the 'plan' task.Four attempts were made to go from one task to the other but the system rebooted itself every time.The cd drive was empty.There was no patient present.

Manufacturer Narrative

Correction: serial number updated to proper value.

Manufacturer Narrative

A review of the logs found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.

• Brand Name: STEALTHSTATION S7 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: heather davis ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7665438
• MDR Text Key: 113283035
• Report Number: 1723170-2018-03182
• Device Sequence Number: 1
• Product Code: HAW
• 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,user f
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2012
• 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