On (b)(6) 2016 a medtronic representative, following-up at the site, reported speaking with the site chief resident who stated that the post-op mri showed that the patient anatomy had shifted from what they were seeing on the navigation system scan they used in the procedure, which was from two weeks before.What the chief resident thinks happened is the anatomy shifted when they were going through the cerebellum.He believes the navigation system was accurate, the post-op scan showed they were where they thought they were.The chief resident stated they would not be performing a second surgery.On (b)(6) 2016 a medtronic representative performed a navigation system check-out, all areas passed.System performed as intended.On (b)(6) 2016 software analysis was unable to determine probable cause with the information provided.Anatomy shift is suspected to be the cause of the reported issue.Review of patient exams finds the exams conformed to medtronic imaging protocol and were sufficient for navigation.
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