Model Number 429888 |
Device Problem
Intermittent Capture (1080)
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Patient Problems
Non specific EKG/ECG Changes (1817); Syncope/Fainting (4411)
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Event Date 01/25/2023 |
Event Type
Injury
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Manufacturer Narrative
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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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Event Description
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It was reported that the patient experienced a significant pause lasting twelve seconds.It was observed that left ventricular (lv) lead exhibited intermittent loss of capture.It was further reported that the right atrial (ra) lead exhibited a high, undefined pacing impedance.Both leads remain in use.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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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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Event Description
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Additionally, it was reported that the patient experienced a syncopal event as a result of this incident.The output was increased and the physician elected to place in epicardial right ventricular (rv) lead as a backup.
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Search Alerts/Recalls
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