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

Model Number S7

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/21/2019

Event Type  malfunction  

Event Description

S7 with axiem was being used during a shunt placement procedure.The axiem was working properly during registration and accuracy confirmation, but box and emitter went to red status about 30 minutes into the case.They reseated the power/communications cable and rebooted the software with no change.Navigation was aborted and the procedure was completed successfully without guidance.Upon inspection of the system, the axiem box and emitter showed green status and worked properly until left on for approx.30 mins when the box and emitter went into red status and would not revert to green.Ts shipped in a replacement axiem box and emitter.Both parts were replaced and the issue has been resolved.

• Brand Name: STEALTH STATION
• Type of Device: NEUROLOGICAL STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC.; 826 coal creek circle; louisville CO 80027
• MDR Report Key: 8981000
• MDR Text Key: 157101949
• Report Number: 8981000
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S7
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2019
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 12045 DA