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

Model Number S7

Device Problems No Display/Image (1183); Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.Return requested.Replacement 4port vga splitter and multiout 350w power supply both shipped to site 04/05/2017.No parts have been received by manufacturer for analysis.-on 04/11/2017 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.- replaced vga splitter and uninterruptible power supply (ups).- no further issues have been reported.

Event Description

A site representative reported that their navigation system monitors, staff and surgeon, were flickering and rendered usable intermittently.Monitor image was compressed to a line at top of the screen, perhaps a fifth or a fourth.No further details regarding the behavior, or specifically when it occurred, were provided.There was no patient present when this issue was identified.

Manufacturer Narrative

The suspect vga splitter was returned to the manufacturer for analysis.The splitter was found to be fully functional with no problem found.The reported event could not be duplicated by medtronic personnel.The suspect power supply was returned to the manufacturer for evaluation.Testing found physical damages from the 9vac plug being inserted into the housing of the power supply.The unit passed functional testing.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.

• 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 ; 7208902187
• MDR Report Key: 6532998
• MDR Text Key: 74039604
• Report Number: 1723170-2017-01795
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• Reporter Country Code: SE
• 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
• Report Date: 06/16/2017

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: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2017
• Initial Date FDA Received: 04/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2013
• 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