It was reported approximately one month post implant of an implantable pulse generator (ipg), that the patient experienced an infection with bacteremia.The patient also experienced pain, discomfort, purulent discharge, redness, swelling and poor wound healing.The ipg system was removed.Due to the patient's underlying rhythm, a replacement right atrial (ra) lead and right ventricular (rv) lead were implanted at the time of explant.However, the implant of these leads was unsuccessful as during the procedure, the two new leads exhibited high thresholds and poor sensing.The leads were capped during the procedure until the following day when a new ipgwas implanted.The rv lead was activated and remains in use.The ra lead remained capped and was replaced.No further patient complications have been reported as a result of this event.
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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