Continuation of d10: 6935m55 lead, 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 two weeks post replacement procedure of the right ventricular (rv) lead, the patient developed a pocket infection.It was noted that the pocket was red and the patient experienced pain, purulent discharge/pus, and swelling.The cardiac resynchronization therapy defibrillator (crt-d) system was removed.No further patient complications have been reported as a result of this event.
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