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

Model Number S7

Device Problems Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 11/22/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Onsite investigation was preformed and the field representative was able to resolve the issue by replacing the navigation system's computer.No further issues were reported.Replaced computer was returned to manufacturer.Analysis of the returned computer is in progress and results are not yet available.A full system check-out was completed and all tests passed.Full system functionality was confirmed and the system was returned to service.

Event Description

A medtronic representative reported that the software became unresponsive in multiple areas within the software during browsing through plans.There was no patient present when this issue was identified.

Manufacturer Narrative

The analysis on the computer of the navigation system was completed by medtronic personnel.Testing found that the ram had a malfunction.However, testing was unable to replicate the reported issue.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.

Manufacturer Narrative

Correction: aware date of follow-up sequence 1 inadvertently entered as (b)(6) 2017.Should have been (b)(6) 2018.

• 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
• MDR Report Key: 7123572
• MDR Text Key: 95078404
• Report Number: 1723170-2017-05181
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/16/2018

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: Health Professional
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 01/16/2018; 01/16/2018
• Supplement Dates FDA Received: 01/16/2018; 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2012
• 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