Model Number H701703 |
Device Problem
Signal Artifact/Noise (1036)
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Patient Problem
Cardiac Arrest (1762)
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Event Date 01/16/2018 |
Event Type
Injury
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Event Description
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During an atrial fibrillation ablation procedure the patient went into cardiac arrest.Noise was noted on the claris system, which resulted in the non-abbott stimulator not being able to apply pacing due to oversensing.The patient went into cardiac arrest but eventually stabilized with no intervention required and the procedure was completed.
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.A review of the device history record was not possible since the system serial number was provided and the component serial number was not.
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Event Description
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During an atrial fibrillation ablation procedure, when the claris system was connected to the non-abbott stimulator there was noise on the system.Due to the over sensing of the noise, pacing could not be applied when the patient went into cardiac arrest, resulting in the patient being asystolic for 4.3 seconds.The patient stabilized with no intervention and the procedure was completed.
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Search Alerts/Recalls
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