|
Model Number 4FC12 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
|
Event Date 08/28/2023 |
Event Type
Injury
|
Event Description
|
It was reported that during a cryo ablation procedure, the patient experienced a pericardial effusion.It was further reported that the effusion occurred following ablation of the left superior pulmonary vein (lspv), left atrial appendage, and right superior pulmonary vein (rspv).It was noted that the patient experienced a significant drop in blood pressure, and the physician visualized a significant effusion using an intracardiac ultrasound catheter.A pericardiocentesis was quickly performed and 1100 ml of blood was removed.The patient left the lab in stable condition and was monitored for further drainage from the pericardium.The patient was in the hospital for two days following the event and was discharged home without any further intervention or issue.The case was aborted while the patient was under general anesthesia.No further patient complications have been reported as a result of this event.
|
|
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.
|
|
Manufacturer Narrative
|
Product event summary: the data files were returned and analyzed.The patient data file analysis could not be assessed, the received data file was corrupted.The failure file was not received.In conclusion, the reported clinical issues (pericardial effusion, blood pressure issue) occurred during the procedure.Additionally, the decision to abort the procedure without use of alternate therapy was based upon the medical judgment of the physician.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
|
|
|