MEDTRONIC NAVIGATION, INC NON-INVASIVE PATIENT TRACKER; NEUROLOGICAL STEREOTAXIC INSTRUMENT
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Model Number 9734887 |
Device Problems
Imprecision (1307); Human-Device Interface Problem (2949)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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No parts have been returned to medtronic for analysis.A medtronic representative went to the site to test the equipment.Testing revealed that the system performed as intended, and no failure was found.The navigation system then passed the system checkout and was found to be fully functional.B01, c19, d14 are applicable.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 for a functional endoscopic sinus surgical procedure.It was reported that the tracer probe was inaccurate after a good registration.The site re-registered a total of eight times to get a passing registration, but when the surgeon used the probe to verify the accuracy, it did not show precisely where the probe was placed.The variance of accuracy changed between each registration.On the last registration, the registration error was 1.0 mm.The navigation looked to be approximately 4 mm off.The entire head except the back was circled in green, while the back of the head was in yellow.The geometry error of the tracing probe was a consistent.4 mm during tracking.The instruments and frame were consistently tracking with no flickering in the tracking view.The manufacturer representative said that the skin quality on the magnetic resonance imaging (mri) scan of the patient looked great.The mri was obtained the day before.Navigation was aborted, and the surgeon said t hey did not wish to open additional products due to backorder.This occurred intraoperatively, and there was a surgical delay of twenty minutes.There was no reported impact to patient outcome.
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Search Alerts/Recalls
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