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

Model Number S7

Device Problems Erratic or Intermittent Display (1182); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.It was found that rhe surgeon monitor was flashing on and off very quickly.It appeared to only be happening when the surgeon was using the bovie.The medtronic representative reported that it seems to be an radiofrequency or electrical interference being caused by the bovie being used.Monitor would flicker when the bovie was in use.The surgeon monitor cord was run through the bovie/bipolar cart.He re-routed the cable around so that it would not run through the cart.The monitor flickered less but continued to flash.The bovie cart was placed directly next to the navigation system so possibly the interference is coming from the location.Site will set up cases with the bovie cart further from the system and the medtronic representatives will continue to monitor.The medtronic representative checked all connections within the navigation system and all were found to be good.When he brought the system out of the room, he could not get the monitor to flicker.The navigation system then passed the system checkout and was found to be fully functional.Upon follow-up with the medtronic representative, he was able to confirm that when the bovie cart was positioned adjacent to the navigation system and the surgeon monitor cable was routed through a gap in the bovie cart before being plugged into the staff cart, then the surgeon monitor would flicker when the bovie was in use.He worked with the site on cart positioning in the operating room (or) and that resolved the issue.

Event Description

A medtronic representative reported on behalf of the site that, while in a spinal fusion procedure, the navigation system's surgeon monitor was 'flickering'.The staff monitor was functioning as expected.There was no reported delay to the procedure due to this issue.There was no impact on patient outcome.

• 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: oksana ditolla ; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6449623
• MDR Text Key: 71475785
• Report Number: 1723170-2017-01432
• 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,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 03/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2017
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2010
• 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
• Patient Age: 64 YR
• Patient Weight: 89