Model Number S7 |
Device Problems
Device Stops Intermittently (1599); 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 12/18/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information not provided due to (b)(6) patient privacy regulations.No procode, common device name and/or 510k provided as this device is not released for distribution in the united states.No parts have returned to the manufacturer for evaluation.No parts returned for analysis.
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Event Description
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A medtronic representative reported that while in a cranial resection procedure the positioning sensor unit (psu) sometimes did not respond/work.The system was rebooted with resolution.The procedure was completed with navigation.There was a reported delay to the procedure of 5 minutes due to this issue and no impact on the patient outcome.
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.
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Manufacturer Narrative
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The polaris spectra system control unit (scu) was returned to the manufacturer for evaluation.After functional testing and visual/physical examination the reported issue could not be confirmed.The scu performed as expected with no issues.A check of the event logs did not reveal any adverse events.No problem was found.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation system being used in a cranial resection.It was reported that the positioning sensor unit (psu) sometime did not respond/work.The system was rebooted with resolution.There was less than an hour in delays.No impact on patient outcome.
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Search Alerts/Recalls
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