Model Number S7 |
Device Problems
Device Stops Intermittently (1599); Communication or Transmission Problem (2896)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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A medtronic representative went to the site to test the equipment.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.No parts were replaced in the system.
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Event Description
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Medtronic received information regarding a navigation device being used for a spinal fusion procedure.The issue occurred intraoperatively during the navigate task and delayed the surgery by less than an hour.It was reported that during the surgery, the system lost connection to the patient frame.The device had intermittent and unexpected connection and was not seeing the patient frame.All other instruments, but the patient frame were seen normally during the procedure.The surgery was completed with the navigation device.
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Manufacturer Narrative
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A software analysis was initiated.However, the software evaluation found that a probable cause was unable to be determined.It was noted that the issue suspected to have been caused by a hardware issue, however the issue could not be confirmed as the reported issue has not recurred.
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Search Alerts/Recalls
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