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

Catalog Number 9735669

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Patient Involvement (2645)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Udi not available for this system at time of filing.Device manufacturing date is unavailable.A medtronic representative went to the site to test the equipment.The navigation system then passed the system checkout and was found to be fully functional.No parts have been received by the manufacturer for evaluation.

Event Description

Medtronic received information regarding an imaging device being used outside of procedure.It was reported that the representative was getting intermittent video signal upon boot-up.Upon some reboots, the representative would get video and upon others, he would not get video and would get the no video detected box.The representative re-seated the hdmi and usb cable for the touch screen, which resolved the issue.

Manufacturer Narrative

Udi updated; manufacturing date updated.

• 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: sarah olhoft ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 7654516
• MDR Text Key: 112859745
• Report Number: 1723170-2018-03068
• 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: 07/12/2018

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: Physician
• Device Catalogue Number: 9735669
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 07/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2018
• 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