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 Consequences Or Impact To Patient (2199)

Event Date 08/10/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.No parts were replaced.No parts have been received by manufacturer for evaluation.Part not returned for evaluation.

Event Description

A medtronic representative reported that during a spinal fusion procedure, both monitors of the navigation system went black and displayed a no signal on the screen.Representative tried moving the mouse but had no change.Hard shutdown of the system was performed and when the system was powered back up the issue was resolved and the system was functioning normally.The procedure was completed with the use of navigation.There was no delay to the procedure as the issue occurred prior to start of procedure.No impact on patient outcome.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The logs for the navigation system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.

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 ; 7208902515
• MDR Report Key: 6848341
• MDR Text Key: 85127979
• Report Number: 1723170-2017-03648
• 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
• Report Date: 12/07/2017

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 Model Number: S7
• Device Catalogue Number: 9733856
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/10/2017
• Initial Date FDA Received: 09/07/2017
• Supplement Dates Manufacturer Received: 08/11/2017; 11/14/2017
• Supplement Dates FDA Received: 11/06/2017; 12/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2013
• 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