Model Number S7 |
Device Problem
Imprecision (1307)
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Patient Problems
No Consequences Or Impact To Patient (2199); Brain Injury (2219); Iatrogenic Source (2498)
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Event Date 10/05/2016 |
Event Type
Injury
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Manufacturer Narrative
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Following the procedure, the medtronic representative noted it was likely the draping caused the reference to move.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 investigation completed.Findings are that the reference moved while draping the patient.Software is functioning as designed.No further issues have been reported.
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Event Description
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A medtronic representative reported that, while in a cranial shunt placement procedure, the surgeon alleged an inaccuracy occurred.The surgeon alleged being approximately 5 millimeters inaccurate.No specific direction of the alleged inaccuracy was provided.Accuracy was verified toward the nose and ear tract before draping.It is unknown if the alleged inaccuracy occurred after the patient had been draped.When the surgeon did not get any fluid after removing the navigation stylet, two more attempts were made.In the second attempt, the surgeon moved more median than the target was showing and fluid came.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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The instructions for use (ifu) which accompanies this device contains the following warnings regarding frame movement: warning: do not bump or reposition the patient reference after registration.Movement of the patient reference will result in inaccurate navigation.If the patient reference moves in relation to the patient anatomy at any time after registration, you must re-register.
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Manufacturer Narrative
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As previously reported "when the surgeon did not get any fluid after removing the navigation stylet, two more attempts were made.In the second attempt, the surgeon moved more median than the target was showing and fluid came.".
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Search Alerts/Recalls
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