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Model Number 5392 |
Device Problems
Failure to Power Up (1476); Unexpected Shutdown (4019)
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Patient Problem
Low Blood Pressure/ Hypotension (1914)
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Event Date 05/30/2021 |
Event Type
Injury
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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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Event Description
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It was reported that the external pulse generator (epg) which was on a pacing dependent patient in the intensive care unit (icu) turned itself off and was unable to be powered back on.At the time of the event, the patient was doing exercise steps with the physiotherapist.There was a drop in blood pressure and it had caused an alarm on the patient monitor.The leads were still connected and battery was fine at the time.The nurse noticed that the epg was off and was unable to turn it back on.It was then swapped out for another unit.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product analysis: analysis was unable to confirm customer comment that the external pulse generator (epg) turned itself off and was unable to be powered back on.Device passed all incoming functional tests.The hanger assembly was bent.The upper case was broken and dented.The main seal was pinched.The display wire was pinched, the wire insulation was not compromised.Battery drawer shorting bar eco was needed.All found defective parts were replaced and all other identified issues were resolved.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.
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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.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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Search Alerts/Recalls
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