Model Number 383069 |
Device Problems
Break (1069); Capturing Problem (2891); Device Sensing Problem (2917); Positioning Problem (3009); High Capture Threshold (3266); Unstable Capture Threshold (3269)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/02/2024 |
Event Type
malfunction
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Event Description
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It was reported during implant that the pacing lead exhibited 'poor pacing thresholds' and 'poor sensing'.The lead position was changed many times, which resulted in lead breakage.The pacing lead was attempted/not used and replaced. 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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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 pacing lead exhibited high and unstable thresholds.
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Search Alerts/Recalls
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