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

Model Number S7

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 04/25/2018

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 representative replaced the digital visual interface (dvi) cable.The navigation system then passed the system checkout and was found to be fully functional.The suspect digital visual interface (dvi) cable was returned for analysis.The cable was found to be in good condition with no faults found.

Event Description

Medtronic received information regarding a navigation device.It was reported that the navigation system was showing no signal on both monitors.When the cables were reseated into the back of the computer, the issue resolved.The issue was reported to be intermittent and only resolved when the cable was seated back into the computer.No complications were reported/anticipated.

Manufacturer Narrative

Additional information: unique device identification (udi) and device manufacture date provided.

• 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: 7534174
• MDR Text Key: 108985102
• Report Number: 1723170-2018-02198
• 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
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2012
• 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