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Model Number 87067 |
Device Problem
Power Conditioning Problem (1474)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2022 |
Event Type
malfunction
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Event Description
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It was reported that during a procedure using a rhythmia hdx signal station they experienced noise and a lack of a signal.There was noise and then no signal when the catheter was introduced into the left atrium.They checked the area with a mapping and diagnostic catheter, confirming signals were present with those catheters, and then withdrew the ablation catheter.They checked the connections, however, they the problem continued.They were ultimately unable to solve the problem.They decided to stop the procedure and reschedule it for a later date.There were no patient complications.It is currently unknown if the signal station is going to be retained by the site or returned for analysis.
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Manufacturer Narrative
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The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
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Search Alerts/Recalls
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