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Device Problem
Electromagnetic Interference (1194)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/13/2023 |
Event Type
malfunction
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Event Description
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During a premature ventricular contraction procedure using ensite x in voxel mode, interference issues resulted in troubleshooting measures that caused a procedural delay.The mode was switched to navx and the procedure was successfully completed with no adverse consequences to the patient.It was noted that there were no magnetics on ensite x.The system was rebooted four times, and the field frame cable was reseated multiple times, without resolution.It was verified that there were no bent pins.The procedure was completed using navx mode with no adverse consequences to the patient.
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Manufacturer Narrative
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Based on the information received, the cause of the reported interference and subsequent delay remains unknown.
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Search Alerts/Recalls
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