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Model Number 10FCC13 |
Device Problem
Leak/Splash (1354)
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Patient Problems
Non specific EKG/ECG Changes (1817); Embolism/Embolus (4438); Heart Block (4444); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 02/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Continuation of d10: product id :pscc100 product type: pulsefield catheter medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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It was reported that during pulsed field ablation procedure, st elevation and heart block were observed for twenty minutes after placing the pulsed field ablation catheter into the left atrium.It was suspected by the physician to be caused by an air bubble.The symptoms resolved after twenty minutes.No intervention was carried out. the case was completed with pulsed field ablation. no further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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