Continuation of d10: product id: 4092-58, serial# (b)(6), implanted: (b)(6) 2004; product id: 4592-53, serial# (b)(6), implanted: (b)(6) 2004; product id: mc1avr1, serial# (b)(6), implanted: (b)(6) 2023; product id: w3dr01, serial# (b)(6), implanted: (b)(6) 2021; product id: 5076-52, serial# (b)(6), implanted: (b)(6) 2023.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 experienced pocket erosion and wound dehiscence approximately one month post implant of a right atrial (ra) lead and a right ventricular (rv) lead, which were connected to an existing implantable pulse generator (ipg).It was reported that the ipg system was exposed to the air and was contaminated but not necessarily infected.The ipg system was explanted and the pocket was debriefed, respected and closed to prevent any future infection.A leadless ipg was then attempted to be implanted in the rv septum.It was reported that intra-operative, the leadless ipg system was caught in previously capped leads.It was reported that there were possible tissue and blood clots between the device and the cup of the delivery system, and the ipg was unable to be retracted into the cup despite flushing.It was also reported that delivery system was bent.The leadless ipg system was attempted/not used and was replaced.No further patient complications have been reported as a result of this event.
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