It was reported that a patient underwent a idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool smart touch sf bi-directional navigation catheter and the patient experienced a heart block av requiring pacemaker.It was reported that during an idiopathic vt case, complete heart block was noticed in the patient.They reported that while ablating on the his bundle, it was noticed that the patient went asystole on the recording system.They reported that they paced from the right ventricle (rv) catheter.The caller then reported that a pacemaker was implanted in the patient.The patient is in stable condition.The physician¿s opinion on the cause of this adverse event was reported as procedure related.The patient¿s outcome from the adverse event was reported as unchanged and required extended hospitalization.Patient stayed overnight instead of going home that day.
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Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
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