Model Number 9735669 |
Device Problem
Imprecision (1307)
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Patient Problems
Tissue Damage (2104); Brain Injury (2219)
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Event Date 12/28/2018 |
Event Type
Injury
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Manufacturer Narrative
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No parts have been received by the manufacturer for evaluation.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess).It was reported that when the health care professional (hcp) entered the brain using the microscope, the hcp verified that they breached the dura.The hcp collaborated with neurology and is patching the breach with duragen and will have an lp shunt while being observed by neurology intensive care unit (icu).Navigation was aborted causing more than an hour delay in the procedure.Patient was affected.The manufacturer representative gave an update about the reported issue.The patient spent 3 days in neuro intensive care unit (icu) and then they were moved to a floor for further treatment with a pic line after white blood cells were found in the cerebrospinal fluid (csf) pulled from the lumbar drain.The health care professional was inaccurate to a quarter of an inch.Accuracy had been verified at the beginning of the case and throughout after it was noticed that the right side, second side where the injury occurred, was not as accurate as the left side had been.They checked the sphenoid and noted that while they were on the roof of the sphenoid the system showed them having a quarter inch to go to hit the roof.
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Manufacturer Narrative
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The software investigation was unable determine the probable cause of the reported issue.If information is provided in the future, a supplemental report will be issued.
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Event Description
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Medtronic received information regarding a navigation system being used in a functional endoscopic sinus surgery (fess).It was reported that when the health care professional (hcp) entered the brain using the microscope, the hcp verified that they breached the dura.The hcp collaborated with neurology and is patching the breach with duragen and will have an lp shunt while being observed by neurology intensive care unit (icu).Navigation was aborted causing more than an hour delay in the procedure.Patient was affected.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Search Alerts/Recalls
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