Model Number 5076-52 |
Device Problems
Capturing Problem (2891); High Capture Threshold (3266)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 04/04/2024 |
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 right ventricular (rv) lead exhibited rising and high thresholds.The right atrial (ra) lead and the right ventricular (rv) lead were removed and replaced due to access occluded.No patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Product event summary: the full lead was returned and analyzed.No anomalies were found.The distal low voltage electrode of the lead was covered in body t issue/fibrotic growth.Visual analysis of the lead indicated apparent explant damage.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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Search Alerts/Recalls
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