Data was reviewed regarding implants and outcomes of leadless implantable pulse generators (ipgs).They described patient deaths; ho wever, the causes of death were unknown and defined as all-cause, thirty-day mortality.There were patients who experienced acute, thirty-day complications which included puncture site events such as arteriovenous fistula and vascular aneurysms.There were patients who experienced deep vein thrombosis, pulmonary embolisms, pericardial effusion, cardiac tamponade, pain, post implant hematomas or hemorrhages, intraoperative cardiac arrest, pericarditis, and unknown vascular complications.There were dislodgments of leadless ipgs and other unknown malfunctions in which there were revisions, replacements, and other interventions.The status of the devices, delivery systems, and introducers is unknown.No additional adverse patient effects or product performance issues were reported.
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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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