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 replicate the reported event.Replacement of the uninterruptible power supply (ups) resolved the issue.No further issues were reported.Replaced ups was not returned to manufacturer for analysis, therefore, no findings are possible.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 navigation system's computer was intermittently rebooting itself.There was no patient present when this issue was identified.

Manufacturer Narrative

Correction: the computer of the navigation system was replaced.Not the uninterruptible power supply (ups) as previously indicated.The computer of the navigation system was returned to the manufacturer for analysis.The computer was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.

• 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: 7123482
• MDR Text Key: 95063063
• Report Number: 1723170-2017-04752
• 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
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• 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: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2011
• 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