It was reported that three weeks post-operatively to a successful cryo ablation procedure, the patient presented to the emergency department with symptoms of sepsis.An atrio-esophageal fistula was discovered and surgical intervention took place in an attempt to repair it.The patient also had a "neurological event" shortly after hospital admission.The patient was hospitalized for an extended period of time.Two weeks after the initial sepsis and fistula onset, the patient passed away.
|
Product event summary: the data files were returned and analyzed.The patient files showed at least 11 applications were performed with balloon catheter without any issue on the date of the event.In conclusion, the reported death and clinical issues for sepsis, stroke, and atrio-esophageal fistula could not be confirmed through analysis of the data files.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.
|