Model Number 5076-52 |
Device Problems
Decreased Sensitivity (2534); Capturing Problem (2891); Impedance Problem (2950); High Capture Threshold (3266)
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Patient Problems
Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
Event Type
Injury
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Event Description
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It was reported, that the right atrial (ra) lead exhibited high thresholds.The ra lead was removed and replaced. no patient complications have been reported, as a result of this event.
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Manufacturer Narrative
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Concomitant medical products: dtba1d1 crt-d, implanted on: (b)(6) 2015.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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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 further reported that the patient experienced suspected occlusion of the left subclavian vein.The ra lead exhibited decreased sensing, an increase in thresholds and increasing impedance.No further 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.Returned product analysis was performed and no anomalies were found.The distal low voltage electrode of the lead was covered in body tissue/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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