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 the patient felt palpitations and thought they may have been in atrial fibrillation (af).A review of a remote transmission indicated that patient was in af.It was further reported that the patient had a device check or in office visit approximately six days later.It was indicated that the generator replacement procedure contributed to the patient's palpitations and af that occurred one day post implant of the crt-d.Reprogramming of the crt-d was performed with the anti-tachycardia pacing turned on at clinic standard and converted patient out of atrial tachycardia/af.Left ventricular safety margin, rate response, and ventricular fibrillation (vf) therapy pattern were changed and pattern and rate logic turned off as the patient is pacemaker dependent.It was also reported that the patient experienced phrenic nerve stimulation (pns) that is related to a competitor lead.The cardiac resynchronization therapy defibrillator (crt-d) remains in use. no further patient complications have been reported as a result of this event.
|