MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number S7 |
Device Problems
Image Reversal (1358); Communication or Transmission Problem (2896)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/27/2016 |
Event Type
malfunction
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Manufacturer Narrative
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A medtronic representative, following-up at the site, reported did not actually see the flip, however, was told that the images were flipped right to left and anterior posterior (ap).The site used views trajectory 1 and trajectory 2 and both images were flipped.Issue resolved at time of call to medtronic technical services.No further issues have been reported.
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Event Description
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A medtronic representative reported that, while in a spine procedure, the imaging system images were flipped upon transferring from the mobile view station (mvs) to the navigation system.They were corrected by rotating and flipping on the navigation system.No further details regarding the behavior, or specifically when it occurred, were provided.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.Issue resolved at time of call to medtronic technical services.
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