MEDTRONIC NAVIGATION, INC. (LOUISVILLE) STEALTHSTATION S7 SYSTEM; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number S7 |
Device Problem
Imprecision (1307)
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Patient Problems
Injury (2348); Iatrogenic Source (2498)
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Event Date 01/11/2017 |
Event Type
Injury
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Manufacturer Narrative
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On 01/30/2017 a medtronic representative, following-up at the site, reported the inaccuracy was alleged to be 5 millimeters.The surgeon did not attempt to pass the needle down through the burr hole in the originally planned trajectory, instead increased the size of the original burr hole 5 millimeters.The surgeon was using an articulating arm and the plan ever updated in the software after the biopsy guide stem/precision aiming device was locked.The issue was likely to be that the angle to trajectory was not calculated by the software as the surgeon did not reach trajectory target using the original burr hole.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 medtronic representative reported that, while in a cranial procedure, reported that the surgeon was unable to navigate the biopsy needle down the plan as expected.The entry point allegedly did not match the plan.No specific measurement, or direction, of the alleged inaccuracy was provided.The medtronic representative noted that this was a result of acquiring too small of a burr hole.Stated was that 'the bone is blocking the trajectory to the target'.The surgeon opted to continue and completed the procedure with the use of the navigation system.There was no delay of therapy.
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Manufacturer Narrative
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Additional information: it was reported that the site was able to complete the procedure, though the entry point did not match that of the plan.The software investigation found that the reported event was unrelated to a software issue.The investigation found that the surgeon inadequately planning for the physical angle stop of the biopsy equipment caused the reported issue.The software functioned as designed.A medtronic representative went to the site to test the equipment.The representative was unable to replicate the reported issue.The hardware, software, and instruments passed the system checkout.The system was found to be fully functional.
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