Model Number S7 |
Device Problems
Device Operates Differently Than Expected (2913); Positioning Problem (3009)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/17/2018 |
Event Type
malfunction
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Manufacturer Narrative
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No parts have been returned to the manufacturer for analysis.A medtronic representative went to the site to test the equipment.Testing revealed that the system performed as intended.
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Event Description
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Medtronic received information regarding a navigation system being used during a catheter placement.It was reported that intra-operatively, the surgeon said the plan was off five millimeters lateral.A manufacturer representative later confirmed with the chief resident that the distance of inaccuracy was around four millimeters.The site was using the passive catheter introducer (pci) tip probe.Surgery was completed using the navigation system.There was no reported surgical delay or patient impact.
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Manufacturer Narrative
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Additional information: medtronic received information that the site confirmed precision on known anatomical landmarks.It was noted that the registration for the procedure included red areas, but had sufficient points to pass.
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Search Alerts/Recalls
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