It was reported that one day post implant, during an right ventricular (rv) lead revision procedure, the right atrial (ra) lead became dislodged.The lead was attempted to be repositioned into the right atrial appendage multiple times but appeared unstable and kept dislodging.The lead was then repositioned to the lateral wall.The patient is a participant in the post approval clinical surveillance product surveillance registry.No 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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