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.
|
It was reported that the right ventricular (rv) lead had an alert of high pacing impedance the day after implant.Two weeks later the patient had chest pain, it was found that there was an alert for low pacing impedances.The rv lead was also noted to have had high threshold, capture could not be confirmed, and a decrease in r-wave amplitude.The lead remains in use.No patient complications have been reported as a result of this event.
|