Model Number 2AF284 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Intracranial Hemorrhage (1891); Nausea (1970); Dizziness (2194)
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Event Date 02/21/2018 |
Event Type
Injury
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that post operatively to a cryo ablation procedure, the patient experienced a pontine hemorrhage and vertigo.A computerized tomography (ct) scan was performed noting the abnormal pontine hemorrhage.The case outcome is unknown.The patient's hospitalization was extended.Additionally, medication was administered to the patient upon discharge.The patient is a participant in the cryo atrial fibrillation (af) clinical study.No further patient complications have been reported as a result of this event.
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Manufacturer Narrative
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If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was further reported that the patient experienced nausea.Medication was administered during the patient's hospital visit.The patient is a participant in the (b)(6) clinical study.
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Search Alerts/Recalls
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