Continuation of d10: cmrm6122 envelope, implanted (b)(6) 2024.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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It was reported that the patient developed an infection approximately five and a half weeks after the implant of a cardiac resynchronization therapy defibrillator (crt-d) with an absorbable envelope.The crt-d system was explanted and a leadless implantable pulse generator (ipg) was subsequently placed.Discomfort, redness, and swelling were also noted and the patient was treated with antibiotics.No further patient complications have been reported as a result of this event.
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