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

Model Number S7

Device Problems Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/29/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A medtronic representative went to site to test the equipment.Representative reported that the computer of the navigation system would freeze and was not booting normally.Representative stated that when attempting to start the system it took three times to boot up.Representative replaced a computer and reinstalled software.A fan cable was damaged when replacing the computer and the fan cable was also replaced.A system checkout was performed and the hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect computer has been received by the manufacturer for evaluation.The suspect fan has not been received by the manufacturer for evaluation.The received computer booted normally to application screen.Cranial program and exams loaded correctly and no unresponsiveness in the software was observed.Computer passed all tests.No fault found.

Event Description

A medtronic representative reported that while outside of procedure, the navigation system would intermittently become unresponsive.Representative was able to replicate the issue.It was reported that the system took longer than usual time to boot and eventually became unresponsive.The system had to be rebooted manually.There was no patient present at the time of the issue.

Manufacturer Narrative

The hardware investigation of the fan found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware 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: peter verhey ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902515
• MDR Report Key: 7212368
• MDR Text Key: 98019737
• Report Number: 1723170-2018-00336
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2018

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 Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2017
• Initial Date FDA Received: 01/23/2018
• Supplement Dates Manufacturer Received: 02/09/2018; 04/06/2018
• Supplement Dates FDA Received: 02/23/2018; 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2013
• 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