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.
|
It was reported that a post-operative interrogation showed that a lead integrity alert (lia) had been triggered by the right ventricular (rv) lead for high rate non-sustained episodes and sensing integrity counter (sic), and ten shocks had been delivered for episodes of ventricular tachycardia/ventricular fibrillation (vt/vf).It was noted by the nurse that the patient underwent open heart surgery during the time of the vt/vf episodes and lia, and a magnet had not been placed over the device during the surgery.It was suspected that the event occurred due to cautery during the open heart surgery.The icd and lead remain in use, and the patient will continue to be monitored.No further patient complications have been reported as a result of this event.
|