Model Number MI2355A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Fistula (1862)
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Event Date 12/23/2021 |
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 during the implant procedure of the leadless implantable pulse generator (ipg), the patient was noted to have a femoral vein arteriovenous fistula and the procedure could not be continued as a result.The sheath was removed and the blood vessel was sutured.The introducer was attempted/ not used.No further patient complications have been reported as a result of the event.
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Event Description
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It was reported that during the implant procedure of the leadless implantable pulse generator (ipg), the patient was noted to have a femoral vein arteriovenous fistula and the procedure could not be continued as a result.The sheath was removed and the blood vessel was sutured.The introducer was attempted/ not used.No further patient complications have been reported as a result of the event.
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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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Manufacturer Narrative
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Product event summary: the introducer was returned and analyzed.No anomalies were found.Blood was observed on the delivery system introducer flush port valve.Blood was observed on the delivery system introducer flush tube.Blood was observed on the delivery system introducer proximal seal.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 second introducer was attempted and not used due to having become contaminated during the implant procedure.
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Search Alerts/Recalls
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