MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC STEALTH STATION NAVIGATION SYSTEM; INSTRUMENT, STEREOTAXIC

Model Number 9733858

Device Problem Failure to Obtain Sample (2533)

Patient Problem No Patient Involvement (2645)

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

Onsite functional and visual examination was performed by a manufacturer representative.The camera was replaced and the issue was resolved.The system passed a system checkout and was returned to an operational condition.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information regarding a navigation system.It was reported that the camera did not see the instruments after the system was booted up.There was no patient present.

Manufacturer Narrative

The position sensor unit (psu) was returned to the manufacturer for analysis.Analysis found that the returned psu powered up with the amber fault light on.A check of the event log indicated a bump was detected (b)(6) 2018.After clearing the bump sensor, the psu returned to normal function.The psu passed an accuracy test (aak) at.11 mm with a passing threshold of.35 mm.The psu is now fully functional.Analysis found that the reported event was related to a electrical issue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: STEALTH STATION NAVIGATION SYSTEM
• Type of Device: INSTRUMENT, STEREOTAXIC
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC; 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stacy ruemping ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635260594
• MDR Report Key: 7948278
• MDR Text Key: 123384187
• Report Number: 1723170-2018-05030
• Device Sequence Number: 1
• Product Code: HAW
• UDI-Device Identifier: 00643169505742
• UDI-Public: 00643169505742
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K050438
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9733858
• Device Catalogue Number: 9733858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1