PERFUSION SYSTEMS CARDIOBLATE; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
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Model Number 49341 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Tachycardia (2095)
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Event Date 03/06/2023 |
Event Type
Injury
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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.If information is provided in the future, a supplemental report will be issued.
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Event Description
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During the same procedure on ((b)(6)2022) a cryoflex probe powered by a cryoconsole, and a cardioblate lp clamp powered by a valleylab ft-10 generator were used.The left atrial appendage was successfully closed and stapled.Left pulmonary vein (lpv) and right pulmonary vein (rpv) conduction block were successfully achieved.On ((b)(6)2023) the patient was found to have mild tachycardia at the 3-month visit.The patient was prescribed lopressor from 12.5mg to 25mg.The patient status is recovering/resolving.The adverse event was deemed by the site as possibly related to the concomitant procedure, the study procedure and to the cryoflex probe and cardioblate lp clamp study devices and not related to the cryoconsole and valleylab ft-10 generator.
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Manufacturer Narrative
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Additional information b5.Medtronic received additional information that the patient outcome status was recovered/resolved on the (b)(6) 2023.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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