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

Model Number S7

Device Problem Erratic or Intermittent Display (1182)

Patient Problem No Patient Involvement (2645)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

No patient involved.A replacement staff monitor was sent to the site for issue resolution.Suspect monitor has not been returned for further evaluation.Note: this mdr was filed locally before midnight mdt on 7/22, but rec¿d an error message b/c our emdr system server is on cdt (one hour ahead) on 7/23 at the time of submission.Resubmitting 7/24/2017 to resolve error.

Event Description

A medtronic clinical specialist (cs) called to report the staff monitor was flickering in the top corner.She took the panel off the staff monitor to check cable connections and briefly saw the flickering occur.She didn't have the surgeon monitor plugged in so couldn't confirm whether it was seen on both monitors or not.No patient involvement.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative reported that the issue was reoccurring at the site.To resolve the reported issue, the video graphics array (vga) splitter was replaced on the navigation system.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect vga splitter has not been received by the manufacturer for evaluation.

Manufacturer Narrative

The splitter was returned to the manufacturer for analysis.When connected to a known good system the returned splitter returned a good image for each output.The image was clear from edge to edge with no flickering.The device was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

Manufacturer Narrative

The software investigation found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.

• 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 ; 7208902092
• MDR Report Key: 6736342
• MDR Text Key: 80808256
• Report Number: 1723170-2017-03024
• 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,user f
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Equipment Company Technician/Representative
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2012
• 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