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Model Number UNK-COMP-LEAD |
Device Problems
Intermittent Capture (1080); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271)
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Event Date 07/18/2022 |
Event Type
Death
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Event Description
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It was reported that the patient is deceased.The patient experienced hypotension, pericardial effusion, perforation and arrhythmia.The patient was being temporarily paced by a right ventricular (rv) lead prior to implant of a leadless implantable pulse generator (ipg).The leadless ipg exhibited intermittent capture after the initial deployment.The temporary rv lead was noted to exhibit intermittent capture.The temporary rv lead was repositioned before the leadless ipg was redeployed.The patient required medication.Pericardiocentesis was performed on the patient.It was noted that the pericardiocentesis procedure required additional assistance and time due to an unsuccessful tap which lead to the patient requiring an external shock and chest compressions. the patient was eventually stabilized and transferred to intensive care unit (icu).The patient stabilized and it was noted that the effusion had closed however the patient died overnight.It was reported the patient¿s family declined emergency measures for the patient.Additional information related to the cause of death was requested and not yet received.
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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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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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It was further reported that the temporary rv lead is an unknown competitor lead.
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Search Alerts/Recalls
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