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)

Patient Problem No Patient Involvement (2645)

Event Date 03/22/2017

Event Type  malfunction  

Manufacturer Narrative

No patient information provided as no patient was involved in this concern.On 03/24/2017 a medtronic representative at the site, performed planned maintenance (pm) and a navigation system check-out, all areas passed in both.System performed as intended both times.- no parts have been received by manufacturer for analysis.- no further issues have been reported.

Event Description

A site representative reported that their navigation system surgeon monitor was experiencing intermittent connection issues.The cables were checked and the signal was transferred, however, sometimes the software showed an orange signal vs.The normal green for a good connection.No further details regarding this issue, or specifically when it occurred, were provided.There was no patient present when this issue was identified.

• 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: judith ericson ; 826 coal creek circle; louisville, CO 80027-9710 ; 7208902187
• MDR Report Key: 6498511
• MDR Text Key: 72985677
• Report Number: 1723170-2017-01645
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00613994450968
• UDI-Public: 00613994450968
• Combination Product (y/n): N
• 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
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• 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: 9733858
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2012
• 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