Model Number S7 |
Device Problems
Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896); Device Operates Differently Than Expected (2913)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/10/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Return requested.Replacement axiem portable shipped to site 11/10/2016.No parts have been received by manufacturer for analysis.On 11/11/2016 a medtronic representative performed a navigation system check-out, software and instruments areas passed.Hardware test failed.Axiem communicator not picking up instruments in the field despite having "green" status, replaced axiem communicator.Issue resolved.System performed as intended.
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Event Description
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A medtronic representative reported that, while in a cranial shunt procedure, the surgeon experienced difficulty tracking the non-invasive patient tracker.They successfully registered the patient and tracked the registration probe, however, when they went to navigate the non-invasive patient tracker (nipt) went to red status.The axiem box and emitter were both showing in green status in the tracking details.Trouble-shooting did not resolve the issue.An alternate navigation system was brought in to be used to continue the procedure to completion.Delay in therapy was less than one hour.There was no impact on patient outcome.
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Manufacturer Narrative
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The axiem box was returned to the manufacturer for analysis.The device tracked properly with no failures.Visual inspection did find physical damage to the usb connector connecting to the computer, however this did not affect function.The device was found to be fully functional.The reported event could not be duplicated by medtronic personnel.The separate issue found, regarding physical damage, was documented in a medtronic navigation hardware anomaly tracking database.
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Search Alerts/Recalls
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