Model Number 5076-58 |
Device Problems
Signal Artifact/Noise (1036); Fracture (1260); High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Capturing Problem (2891); High Capture Threshold (3266)
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Patient Problems
Arrhythmia (1721); Dizziness (2194); Discomfort (2330)
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Event Date 11/01/2023 |
Event Type
Injury
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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 reported that the patient experienced palpitations, slight dizziness, discomfort in chest and complained poor physical condition.The right ventricular (rv) lead exhibited high undefined impedance in unipolar and bipolar configuration.High and increase in threshold was also noted. when an electrocardiogram was taken, a ventricular pacing failure was confirmed.Noise observed at non-sustained ventricular tachycardia episodes and sensing integrity counter (sic) was high.Lead fracture was suspected.Hospitalization was required as a result of the event.The lead remains in use.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 lead was not returned for analysis, however, performance data collected from the device was received and analyzed.Analysis of the device memory indicated oversensing associated with the right ventricular lead.Analysis of the device memory indicated the impedance of the right ventricular pacing lead was beyond the expected upper range.Analysis of the device memory indicated the impedance trend of the right ventricular pacing lead was rising.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 noise.Analysis of the device memory indicated oversensing due to non-physiologic signals/sensing integrity counter.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.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 rv lead was explanted and replaced.
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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 rv lead remains in the patient as could not be explanted.
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Search Alerts/Recalls
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