Model Number S7 |
Device Problems
Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138); Device Operates Differently Than Expected (2913)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 05/22/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Patient information not provided due to (b)(6) patient privacy regulations.No procode, common device name, unique device identification(udi) and/or 510k provided as this device is not released for distribution in the united states.Device manufacturing date is unavailable.A medtronic representative went to the site to test the equipment.Testing revealed that the reported issue could not be replicated.The system then passed the system checkout and was found to be fully functional.
|
|
Event Description
|
Medtronic received information regarding a navigation system being used in a sacroiliac and thoracolumbar procedure.It was reported that the system suddenly turned off.The system was rebooted, and the exams were transferred already so the procedure continued without further action.There was no delay to procedure.No known impact on patient outcome.
|
|
Manufacturer Narrative
|
Additional information: unique device identification (udi) and device manufacture date provided.Correction: no 510(k) provided as this device is not released for distribution in the united states.
|
|
Manufacturer Narrative
|
A software analysis was initiated to determine the probable cause of the issue through known anomaly determination.Analysis found that the reported event was related to a software issue.This issue was documented in a medtronic navigation software anomaly tracking database.
|
|
Search Alerts/Recalls
|