Model Number 5076-52 |
Device Problems
Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Under-Sensing (1661); Capturing Problem (2891); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2024 |
Event Type
Injury
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Event Description
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It was reported that the right ventricular (rv) lead became dislodged due to suspected ratchet and exhibited high and rising thresholds, no capture, noise, undersensing, oversensing and not sensing.The lead was reprogrammed before it was explanted and replaced.It was noted that the lead tip was already retracted almost to the pocket.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 right ventricular undersensing.Analysis of the device memory indicated pacing capture threshold in the right ventricle was elevated.Analysis of the device memory indicated pacing capture threshold in the right ventricle was rising.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.Analysis of the device memory indicated oversensing associated with the right ventricular lead.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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