MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number S7 |
Device Problems
Computer Software Problem (1112); Image Reversal (1358)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/01/2016 |
Event Type
malfunction
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Manufacturer Narrative
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On 09/02/2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On 09/27/2016 a medtronic representative, following-up at the site, reported the issue was discovered during the beginning of procedure.With this particular software, once the surgeon makes an incision, the device cannot be switched for another.No impact on patient outcome.No parts were replaced.No parts have been received by manufacturer for analysis.No further issues have been reported.
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Event Description
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A site representative reported that, while in an ortho-hip procedure, using universal imageless hip software, their inclination and anteversion numbers were flipped.The surgeon used another navigation system to continue the procedure.No further details regarding this issue, or specifically when it occurred, were provided.The surgeon completed the procedure with the use of the navigation system.There was no delay of therapy.There was no impact on patient outcome.
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Manufacturer Narrative
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A medtronic representative reported that he was unable to replicate the issue.He uninstalled and reinstalled software as a precaution.The software investigation found that a probable cause was unable to be determined without further information since the behavior could not be replicated.
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Search Alerts/Recalls
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