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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It was further reported that the patient experienced an infection with draining of a cutaneous sinus tract right above the site of the leads and constant "seeping" from the site.The patient was administered antibiotics.It was noted that the infection was only present on the leads.A procedure was performed with a plan to remove the cardiac resynchronization therapy defibrillator (crt-d) system but upon opening the pocket it was noted that the lv lead was directly under the site and was suspected to be causing a possible pressure effect leading to irritation and opening of the wound.There was no evidence of an infection in the pocket, but the pocket was irrigated with antibiotic solution, the leads were not removed but the cardiac resynchronization therapy defibrillator (crt-d) was placed in an antibiotic envelope and returned to the pocket.The patient is a participant in a clinical study.The crt-d and leads remain in use.No further patient complications have been reported as a result of this event.
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