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

Model Number S7

Device Problem Unstable (1667)

Patient Problem No Patient Involvement (2645)

Event Date 01/30/2017

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 suspected that the reported event was caused by the surgeon monitor and the external cable.Replacement of the aforementioned parts resolved the issue.No further issues were reported.Analysis of the returned external monitor cable could not confirm any failure as it passed bench testing and operated without any issues.The replaced monitor 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 site representative reported that the port, where the navigation system's surgeon monitor cable plugs into, felt loose and they sometimes lost video signal if that connection was manipulated.There was no patient present when this issue was identified.

Manufacturer Narrative

A medtronic representative reported that the monitor cord was replaced and not the monitor.The monitor was indicated as previously being replaced when it has not been replaced.

• 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 ; 826 coal creek circle; louisville, CO 80027
• MDR Report Key: 6352611
• MDR Text Key: 68127145
• Report Number: 1723170-2017-00847
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Radiologic Technologist
• Device Model Number: S7
• Device Catalogue Number: 9733856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2015
• 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