Unique device identifier (udi) is unavailable.No parts have been received by the manufacturer for evaluation.Device manufacture date is unavailable.Other relevant device(s) are: product id: 28322, serial/lot #: unk.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that, while in an electrode and probe placement procedure, the patient bled more than anticipated.It was suspected the issue was due to an increased incision size for the drill guide.There was a reported delay to the procedure of less than 1 hour due to this issue.There was no reported impact on patient outcome.Medtronic received information that the incision was 6mm which was larger than the anticipated 3mm incision for stereoelectroencep halography (seeg) procedures.Additionally, it was suspect that the surgeon was tapping the drill guide against tissue rather than bone as indicated in the workflow for the automated guidance unit.Additionally, no additional intervention was required for the bleed.
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