PERFUSION SYSTEMS CARDIOBLATE G2; SURGICAL DEVICE, FOR CUTTING, COAGULATION, AND/OR ABLATION OF TISSUE, INCLUDING
|
Back to Search Results |
|
Model Number 68000 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problem
Arrhythmia (1721)
|
Event Date 09/21/2023 |
Event Type
malfunction
|
Event Description
|
The patient had a concomitant surgical procedure of coronary artery bypass graft (cabg) through sternotomy.During the same procedure on the (b)(6) 2023) a cryoflex probe powered by a cryoconsole, a cardioblate maps model and a cardioblate lp clamp powered by a cardioblate generator were used.The left atrial appendage was amputated/excised and oversewn.Left pulmonary vein (lpv) and theright pulmonary vein (rpv) conduction block were successfully achieved.On the (b)(6) 2023) the patient experienced ventricular premature contractions (vpcs).The ert holter report showed frequent vpcs, more than thirty in one hour.The adverse event was deemed by the site as unlikely related to the concomitant procedure, the study procedure and the study devices.The adverse event was deemed by the sponsor as not related to the concomitant procedure, the study procedure and the study devices.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|