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.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 the patient was found with pulseless electrical activity.The patient was taken by ambulance to the hospital where they were unresponsive and having multiple seizures.It was determined that the right ventricular (rv) lead was undersensing the r waves during a ventricular fibrillation (vf) arrest which led to a delay in therapy.In addition, the lead triggered a lead integrity alert (lia) for sensing integrity counter (sic) and high-rate non-sustained episodes; however, the alert appeared to be a false positive due to the rv lead undersensing.The patient was put on life support and programming changes were made but the patient had sustained permanent injury and passed away ten days later from vf arrest.
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