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 reported that during the implant of the right ventricular (rv) lead, due to the abnormal anatomical structure of the patient's heart, the lead could not stably adhere to the interval.Several positioning attempts were made but good electrical parameters could not be obtained, and the thresholds were high.After several attempts to position the lead, the physician took out the lead.The physician was concerned that the tip of the lead would be slightly deformed after being rotated out many times and that this would affect the fixation of the helix.For the safety of the patient the physician did not implant the lead and a new lead was implanted into the apex of the patient's right ventricle with good parameters.In addition, during the implant of the right atrial (ra) lead, due to the abnormal anatomical structure of the patient's heart, the lead could not be attached to the right atrial appendage and could not be fixed after multiple attempts.The patient¿s blood pressure dropped at this time.For safety reasons, this ra lead was not used, and a new ra lead was implanted with good parameters after fixation.The patient was hospitalized as a result of this event.No further patient complications have been reported as a result of this event.
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