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Model Number EP-4-04 |
Device Problem
Pacing Problem (1439)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/26/2022 |
Event Type
malfunction
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Event Description
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During a procedure, pacemakers were present during pacing, however, there was no capture.Pacing was done at 10ma/2ms, then increased to 20ma/2ms which did not resolve and pacing could be done on all channels.The stim cables were disconnected and reconnected which did not resolve the issue.The system was power cycled, the bnc cable connection from the ep-4 to the carto system was checked and confirmed to be ok.The issue did not resolve and the procedure was aborted.
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Manufacturer Narrative
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One workmate¿ claris¿ ep-4¿ cardiac stimulator was received for investigation.Visual inspection of the returned product confirmed all input and output connectors are free of physical damage and all labeling is legible and correctly oriented.Normal wear was indicated on the exterior chassis which is consistent with clinical usage.The attenuator in use and blanking setting were not provided for this analysis.The user should confirm synchronization performance during operation and adjust the synchronization sense level, synchronization delay, setup level % parameter and the setup blanking interval if necessary.Performance can be monitored by the synchronization interval and/or monitoring the sense marker output signal on the rear panel of the ep-4¿ cardiac stimulator.The returned cardiac stimulator functioned as anticipated during the evaluation period.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.No non-conformances associated with the reported event were identified.Based on the information provided to abbott and the investigation performed, the root cause of the reported event and subsequent cancellation remains unknown.
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Search Alerts/Recalls
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