Catalog Number 9735669 |
Device Problem
Device Stops Intermittently (1599)
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Patient Problem
No Patient Involvement (2645)
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Event Date 04/26/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No patient information provided as no patient was involved in this concern.Udi not available for this system at time of filing.Device manufacturing date is unavailable.No parts have been received by the manufacturer for evaluation.
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Event Description
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Medtronic received information regarding a navigation device.It was reported that the system was working, unplugged from the wall, moved to the operating room, and re-plugged to the wall.That was when it was identified the emitter was not working.It was working prior to the move.It was indicated changing the setup in the room had not resolved the issue.Unplugging the emitter and reconnecting it also had not resolved the issue.Additional information received reported that the emitter had been working since the reported issue.No complications were reported/anticipated.
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Manufacturer Narrative
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Additional information: unique device identification (udi) and device manufacture date provided.The logs for the navigation system were reviewed by medtronic personnel.However, the logs provided no additional insight into the probable cause of the anomaly.
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Manufacturer Narrative
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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 device.It was reported that the system was working, unplugged from the wall, moved to the operating room, and re-plugged to the wall.That was when it was identified the emitter was not working.It was working prior to the move.It was indicated changing the setup in the room had not resolved the issue.Unplugging the emitter and reconnecting it did the issue.No complications were reported/anticipated.
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Manufacturer Narrative
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Aware date correction for supplemental report follow up 002.Report # 1723170-2018-02210.Aware date should be (b)(4) 2018.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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