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, post-operatively, the right ventricular (rv) left bundle branch lead exhibited diminished sensing.The device was pacing below the programmed rate during night.T waves were large and occasional premature ventricular contractions (pvc) were also observed.The lead was reprogrammed.The lead and the implantable pulse generator (ipg) remain in use.No further patient complications have been reported as a result of this event.
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