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Model Number MI2355A |
Device Problem
Use of Device Problem (1670)
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Patient Problems
Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Rupture (2208); Loss of consciousness (2418)
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Event Date 07/15/2021 |
Event Type
Death
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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 patient is deceased.During the implant of the leadless implantable pulse generator (ipg) deployment was performed four times.The leadless ipg catheter was taken out of the body and a flush was attempted before the fifth deployment.It was also reported that introducer sheath had moved around to the puncture site and subsequently the introducer sheath was inserted into the incorrect vessel against resistance causing a puncture in the inferior vena cava.During fifth deployment after the tether cutting, it was observed that the arterial pressure had dropped.Since the venous dissociation was concerned when the introducer sheath was inserted, contrast enhanced computerized tomography (ct) from the inferior vena cava was performed that showed an abnormality in the vein, the sediment formed around the iliac vein.While noradrenaline was rapidly administered, the tether cut was completed once.It was decided that a laparotomy was required as well for the patient to arrest hemorrhage at the site.When the abdomen was opened to the upper part, ruptures were found at site near the inferior vena cava that arrest of hemorrhage required for a long time since the blood vessels were tattered.Although the setting of the leadless ipg was set to high output, loss of consciousness was observed, and cardiac arrest completely occurred and the patient died.
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Manufacturer Narrative
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Product event summary: a partial introducer was returned, analyzed, and no anomalies were found.The delivery system introducer sheath was kinked/buckled.The sheath of the delivery system introducer was damaged.Visual analysis of the introducer indicated damage during use.The analyst noted only two segments of the sheath of the introducer were returned.The distal edge of the sheath of the introducer was damaged.The sheath of the introducer was kink buckled at 16.3 cm, 19.9 cm, 28.5 cm, and 35.8 cm from the distal end of the sheath of the introducer.The sheath of the introducer was cut at 31 cm and 38.2 cm from the distal end of the sheath of the introducer.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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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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Manufacturer Narrative
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Correction: h6.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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