Model Number S7 |
Device Problem
Poor Quality Image (1408)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/09/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Patient information was unavailable from the site.A software analysis was performed using the patient exams.The manufacturer representative noticed that the spacing in the slices were different when low and high dosages meet.The manufacturer representative suggested that the site uses the same spacing throughout even when changing to a lower dosage.
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Event Description
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Medtronic received information regarding a navigation device being used outside of a procedure.It was reported that the images loaded were missing anatomy when viewed in the dicom.Loading on the cranial application results in images missing from the top of the head.There was no patient present when this issue was observed.
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Manufacturer Narrative
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A software investigation analysis was initiated to determine the probable cause of the issue through review of the reported issue.Analysis found that the behavior described is the intended behavior of the software.The exams were not to protocol, with non-contiguous slices.Software is functioning as designed.Analysis found that the software functioned as designed.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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