It was reported that one day post-implant, the patient experienced significant discomfort on their left side, beneath their breast.The patient had experienced a cardiac perforation.An x-ray determined that there was a notable loss of slack in the right ventricular (rv) lead.The rv lead exhibited loss of capture and undersensing.A revision was performed to reposition the lead, and the lead remains in use.No further patient complications have been reported as a result of this event.
|
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.
|