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Model Number AAS00161-20 |
Device Problems
Component Missing (2306); Radiofrequency Interference (RFI) (2314); Device Displays Incorrect Message (2591)
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Patient Problem
Pneumothorax (2012)
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Event Date 03/21/2019 |
Event Type
Injury
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Manufacturer Narrative
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Pneumothorax is a known short-term complication when a lung biopsy is performed during a transbronchial lung biopsy or ct guided percutaneous biopsy.If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a procedure, the patient sensor was placed laterally and did not stick to patient and was also outside of magnetic field.Navigation was completed with a nurse having to secure the patient sensor to the patient's body.The physician said the issue was the sensor not maintaining electrical contact.After the procedure the patient was reported to have pneumothorax of the left side.
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Manufacturer Narrative
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Evaluation summary: procedure recordings log analysis showed no software malfunction found, software operated as expected.The complaint was verified.According to analysis, one of the patient sensors was positioned at the edge of the sensing volume.After troubleshooting the first patient sensor out of sensing volume event the sensor was placed within the sensing volume.Several out of sensing volume events continued to occur during the procedure.The user was able to complete the fourth automatic registration, which according to analysis was sufficient, and navigate to the target area.During analysis it was observed that the catheter was navigated in close proximity to the pleura.No other unusual events were observed during log analysis, software operated as expected.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.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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Manufacturer Narrative
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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.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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Search Alerts/Recalls
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