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 the patient presented to the emergency room feeling a shocking/electricity pain pulsing in the neck and down to the arm that was consistent with extracardiac stimulation.The patient also reported that one of the leads was ¿broken/fractured¿ but not certain which lead.The patient also felt that the cardiac resynchronization therapy defibrillator (crt-d) was ¿malfunctioning¿, and the battery was about to stop.A chest x-ray was ordered but results were not provided.Clinicians indicated that the patient was fine.Following the emergency room visit, the patient believed the lead ¿broke off¿ in the arm and that the lead in the pocket was moving a ton.The device and lead remain in use.No further patient complications have been reported as a result of this event.
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