Model Number 4543 |
Device Problem
High impedance (1291)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 10/06/2022 |
Event Type
malfunction
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Event Description
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It was reported that this left ventricular (lv) lead exhibited pacing impedance values of greater than 3000 ohms on all tested vector configurations.Patient experienced stimulation during lv lead vector testing.It was noted that patient had an echocardiogram.Technical services (ts) analyzed presenting electrogram (egm) and found that there was no loss of capture.Subsequently, ts provided troubleshooting including testing impedances measurements on other vectors.Lead replacement was recommended.Patient is scheduled for an echocardiogram.No additional adverse patient effects were reported.Currently, this lead remains in service.
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Manufacturer Narrative
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Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the lead was performed.Testing was completed to assess lead electrical performance.Measurements were within normal limits.Microscopic inspections of the terminal pin assembly, lead body, and electrode tip found no anomalies.Laboratory testing was unable to reproduce the reported clinical observations and detailed analysis did not reveal any abnormalities.Laboratory analysis did not identify any lead characteristics that would have caused or contributed to the reported clinical observations.
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Event Description
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It was reported that this left ventricular (lv) lead exhibited pacing impedance values of greater than 3000 ohms on all tested vector configurations.Patient experienced stimulation during lv lead vector testing.It was noted that patient had an echocardiogram.Technical services (ts) analyzed presenting electrogram (egm) and found that there was no loss of capture.Subsequently, ts provided troubleshooting including testing impedances measurements on other vectors.Lead replacement was recommended.Patient is scheduled for an echocardiogram.No additional adverse patient effects were reported.Currently, this lead remains in service.Later, this product was received by boston scientific and full investigation was conducted.
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Search Alerts/Recalls
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