Model Number MC1AVR1 |
Device Problems
Failure to Capture (1081); High impedance (1291); Pacing Problem (1439); Material Integrity Problem (2978); Unstable Capture Threshold (3269)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2024 |
Event Type
malfunction
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Event Description
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It was reported intra operatively that the leadless implantable pulse generator (ipg) exhibited high impedance values due to tissue being attached to it, pacing malfunction and unstable thresholds.It was also noted that the delivery system exhibited a hard and would not move smoothly and that the tether may be broken.The leadless ipg and delivery system were 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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Corrected b5 (second sentence) and h6: fdd code 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 intra operatively that the leadless implantable pulse generator (ipg) exhibited high impedance values due to tissue being attached to it, pacing malfunction and unstable thresholds.It was also noted that the delivery system was hard and would not move smoothly.The leadless ipg and delivery system were 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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Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.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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