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

Model Number S7

Device Problems No Display/Image (1183); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The representative reported that the vga splitter for the navigation system was replaced.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.The suspect splitter was returned to the manufacturer for evaluation.Testing found that the splitter had no video for any of the outputs.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Event Description

A site representative reported that, while in a cranial resection, the navigation system displayed there was no input on the monitor.The reported issue occurred when in the middle of the procedure.Restarting the navigation system did not resolve the reported issue.The surgeon opted to complete the procedure without the use of the navigation system.Following the procedure, a medtronic representative restored functionality by bypassing the vga splitter.There was no impact on patient outcome.No additional information was provided.

Manufacturer Narrative

Additional information: there was a total delay of 20-minutes to the procedure.

Manufacturer Narrative

Correction: manufacturer date is 12/2/2010.

• 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: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7176824
• MDR Text Key: 96817554
• Report Number: 1723170-2018-00139
• 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: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2018

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?: Yes
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 08/29/2018; 08/30/2018
• Supplement Dates FDA Received: 08/29/2018; 08/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2010
• 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: 3 YR
• Patient Weight: 15