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

Model Number S7

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.A manufacturer representative went to the site to test the equipment.The computers were replaced.The navigation system then passed the system checkout and was found to be fully functional.The computer (lot # 1777076) was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The suspect computer (lot # 1766760) was returned to the manufacturer for evaluation.However, results are not available at this time.

Event Description

Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that when booting the system, it took a while to select the application.System suddenly became unresponsive while site was selecting the patient.Site attempted reboot, but display was blank.Site noted that system's fans were running at this time.Twenty minutes passed and site attempted another reboot.Application took a long time to launch, but reboot was successful.There was no patient present when this issue was observed.

Manufacturer Narrative

A software analysis was initiated.However, the software evaluation found no software anomaly.Software functioned as designed.

Manufacturer Narrative

A second computer for the navigation system was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

Manufacturer Narrative

Correction: medtronic representative reported that previously reported second computer (lot # 1766760) was returned unused.

• 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: koko tyler ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7208903200
• MDR Report Key: 7604012
• MDR Text Key: 111146304
• Report Number: 1723170-2018-02663
• Device Sequence Number: 1
• Product Code: HAW
• 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,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/12/2018

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: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/14/2018
• Supplement Dates Manufacturer Received: 08/01/2018; 08/28/2018; 09/05/2018
• Supplement Dates FDA Received: 08/23/2018; 09/05/2018; 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2009
• 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