Model Number S7 |
Device Problem
Imprecision (1307)
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Patient Problem
Iatrogenic Source (2498)
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Event Date 11/15/2017 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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A medtronic representative reported that, while in a vp shunt placement, the initial attempt did not draw any cerebrospinal fluid (csf).It was reported that the navigation system displayed the catheter was in the ventricle.A second plan was made by the surgeon as well as a second incision and the site was able to draw cerebrospinal fluid (csf).The surgeon was reported to have confirmed accuracy throughout the procedure.There was a reported delay to the procedure of less than 1 hour due to this issue.No additional information was provided.
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Manufacturer Narrative
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The software investigation found that a probable cause was unable to be determined without further information since the on-going investigation proved to be inconclusive based on the information provided.
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Manufacturer Narrative
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Patient weight needed to be corrected.If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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