Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Complete Heart Block (2627)
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Event Date 07/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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Investigation results will be provided in the final report.Further information regarding the event were requested but not received.
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Event Description
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During a procedure, heart block occurred.The catheter brushed against the membrane of the fossa ovalis, causing heart block.Pacing off the coronary sinus catheter was performed to resolve the heart block.The procedure was completed and the patient was stabilized.
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Manufacturer Narrative
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An event of heart block was reported.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.Further information regarding the event were requested but not received.
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Search Alerts/Recalls
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