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 the patient was seen in-clinic for a device check, and loss of capture was noted on the right ventricular (rv) lead in the bipolar configuration.Due to the patient not requiring pacing in the rv, the pacing polarity was changed to tip-to-coil even though manual threshold measurements were above expected ranges in this configuration.Lead trends also showed pacing impedance had been high but stable.The rv lead remains in use. no patient complications have been reported as a result of this event.
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