Model Number V273 |
Device Problems
Signal Artifact/Noise (1036); Over-Sensing (1438)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/29/2022 |
Event Type
Injury
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Event Description
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It was reported that this cardiac resynchronization therapy pacemaker (crt-p) system exhibited oversensing in the right atrial (ra) and right ventricular (rv) channel.The device was programmed with the ra sensing turned off, technical services (ts) suspected the signs and non physiologic noise and recommended to bring the patient into the clinic to do isometrics to recreate the noise and to continue to monitor.This crt-p system remains in service.No adverse patient effects were reported.Additional information was received which indicated that, this crt-p was explanted and replaced.No additional adverse patient effects were reported.
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Manufacturer Narrative
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The returned device was thoroughly inspected and analyzed.Visual inspection identified no anomalies.The device was able to be interrogated and a memory download was performed successfully.The device was then exposed to simulated heart load conditions, and the defibrillation and sensing functions were tested.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.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 pacemaker (crt-p) system exhibited oversensing in the right atrial (ra) and right ventricular (rv) channel.The device was programmed with the ra sensing turned off, technical services (ts) suspected the signs and non physiologic noise and recommended to bring the patient into the clinic to do isometrics to recreate the noise and to continue to monitor.This crt-p system remains in service.No adverse patient effects were reported.Additional information was received which indicated that, this crt-p was explanted and replaced.No additional adverse patient effects were reported.
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Search Alerts/Recalls
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