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

Model Number S7

Device Problems Computer Software Problem (1112); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2016

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was reported to be involved in this concern.No findings possible at this time.No parts have been replaced, no parts have been received by manufacturer for analysis.Insufficient information, part not received.

Event Description

A site representative reported that the navigation system was intermittently unresponsive following the software update.Site did not report presence of any patient when this issue was identified.

Manufacturer Narrative

A medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.

Manufacturer Narrative

Additional information: a medtronic representative reported that the issue occurred while setting up the equipment for a procedure.A medtronic representative reported that the issue was caused by use error.Additionally, that the cranial tools were installed onto the navigation system.The software investigation found that the reported event was unrelated to a software issue.The software functioned as designed.

• Brand Name: STEALTHSTATION S7 SYSTEM
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LITTLETON); 300 foster street; littleton MA 01460
• Manufacturer Contact: peter verhey ; attn:product quality experienc; 826 coal creek circle; louisville, CO 80027-9710
• MDR Report Key: 6193061
• MDR Text Key: 62976194
• Report Number: 1723170-2016-05755
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450944
• UDI-Public: 00613994450944
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• 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?: Yes
• Date Manufacturer Received: 05/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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