MEDTRONIC, INC. BP2 ABLATION DEVICE BIOPOLAR DEVICE; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
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Model Number 60831 |
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 09/03/2020 |
Event Type
Injury
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Event Description
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The patient had a concomitant surgical procedure of mitral valve repair, tricuspid valve repair, and coronary artery bypass grafting (cabg) (number of anastomoses, four) through sternotomy on the (b)(6) 2019.On the day of the procedure a cryoflex probe powered by a cryoconsole, and a cardioblate bp2 clamp and cardioblate maps powered by a cardioblate generator were used.The left atrial appendage was successfully over sewn.Left pulmonary vein (lpv) block was achieved and right pulmonary vein (rpv) conduction block were achieved.On (b)(6) 2020 the patient experienced non-sustained ventricular tachycardia. six episodes were reported on the holter monitor report.The patient status was recovered/resolved on the (b)(6) 2020.The adverse event was deemed by the site as possibly related to the concomitant procedure, unlikely related to all of the study devices and possibly related to the study procedure.The site provided the following rationale for relating the adverse event to the concomitant and study procedures; cannot rule out, it¿s an arrhythmia.
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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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