Model Number G247 |
Device Problems
Signal Artifact/Noise (1036); Failure to Capture (1081); Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); High Capture Threshold (3266)
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Patient Problem
Device Overstimulation of Tissue (1991)
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Event Date 11/01/2022 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise, oversensing and pacing inhibition on the right ventricular channel and high capture thresholds on the right atrial and left ventricular channels.Additionally, the right atrial lead was exhibiting muscle stimulation, oversensing and loss of capture.X-rays were performed which were inconclusive.Reprograming of the device and a potential lead revision were discussed.This device was explanted and another one was implanted instead.This device is expected to be returned for analysis.No further adverse patient effects were reported.
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Manufacturer Narrative
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Additional information corrected on the following fields: h6: impact codes.
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Event Description
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It was reported that this cardiac resynchronization therapy defibrillator (crt-d) exhibited noise, oversensing and pacing inhibition on the right ventricular channel and high capture thresholds on the right atrial and left ventricular channels.Additionally, the right atrial lead was exhibiting muscle stimulation, oversensing and loss of capture.X-rays were performed which were inconclusive.Reprograming of the device and a potential lead revision were discussed.This device was explanted and another one was implanted instead.This device is expected to be returned for analysis.No further adverse patient effects were reported.
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Manufacturer Narrative
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The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.Dimensional analysis of the header was completed.Each port measured as expected.Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device 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 cardiac resynchronization therapy defibrillator (crt-d) exhibited noise, oversensing and pacing inhibition on the right ventricular channel and high capture thresholds on the right atrial and left ventricular channels.Additionally, the right atrial lead was exhibiting muscle stimulation, oversensing and loss of capture.X-rays were performed which were inconclusive.Reprograming of the device and a potential lead revision were discussed.This device was explanted and another one was implanted instead.This device is expected to be returned for analysis.No further adverse patient effects were reported.
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Search Alerts/Recalls
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