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

Model Number S7

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.No parts have been returned to the manufacturer for evaluation.No parts have returned to the manufacturer.

Event Description

A site physician reported that, outside of a procedure, both screens flicker on the navigation system after it is powered on.There was no patient present when this issue was observed.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative reported that the graphics card of the computer was cleaned to resolve the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

• 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 ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7070860
• MDR Text Key: 93502326
• Report Number: 1723170-2017-04878
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: CN
• 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
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: S7
• Device Catalogue Number: 9733858
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2012
• 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