Model Number 407652 |
Device Problems
Over-Sensing (1438); Under-Sensing (1661); Capturing Problem (2891); Impedance Problem (2950); Unstable Capture Threshold (3269)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/21/2024 |
Event Type
malfunction
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Event Description
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It was reported that the right atrial (ra) lead exhibited undersensing , far field r-wave (ffrw), variable and increased pacing thresholds and slight decrease of the lead impedance.Ra lead remains in use. no 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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Manufacturer Narrative
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Product event summary: the lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated atrial oversensing due to far-field r-waves.Analysis of the device memory indicated the impedance trend of the atrial pacing lead was decreasing.Analysis of the device memory indicated the atrial pacing capture threshold was rising.Analysis of the device memory indicated pacing capture threshold in the atrium was unstable.Analysis of the device memory indicated atrial undersensing.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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