Manufacturer's ref.No: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: shushan zhang.Zhang yanhe.Chang dong.Yan zong yang.Catheter ablation for atrial tachyarrhythmia; observation of long-term prognosis of fast and slow syndrome.Chinese journal of cardiac pacing and electrophysiology 2020 year no.34 volume no.4 period.No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted, and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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.Note: field d4.Catalog should reflect as unk_smart touch bidirectional sf.
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This complaint is from a literature source.The following literature cite has been reviewed: shushan zhang.Zhang yanhe.Chang dong.Yan zong yang.Catheter ablation for atrial tachyarrhythmia; observation of long-term prognosis of fast and slow syndrome.Chinese journal of cardiac pacing and electrophysiology 2020 year no.34 volume no.4 period.Objective/methods/study data: objective: catheter ablation has been used for the treatment of tachycardia-bradycardia syndrome (tbs.However, data on its long-term effect of rhythm control and stroke are limited.Method: patients with tbs admitted in the first affiliated hospital of dalian medical university from 2002-2013 were reviewed in the present study.A total of 150 patients were enrolled.Seventy-nine patients underwent catheter ablation (ca group) and 71 patients chose implantation of pacemaker (pm group.Results : two groups were followed up.The ca group underwent 1 2.± 0 5.Procedure.Of these, 70.9% patients exhibited sinus rhythm without long pauses or the need of anti-arrhythmia drugs.By contrast ,no patient in pm group was free of atrial fibrillation (af).A higher proportion in pm group progressed to persistent af than in ca group.The incidence of new-onset stroke in pm group was significantly higher than that in ca group, despite higher rates of anticoagulation prescription ( there was no mention of when strokes were noted within the 10 year follow up period).Conclusions catheter ablation is effective for preventing both the tachycardia and bradycardia components for the majority of patients with tbs without the need for further pacemaker implantation.Moreover, ablation can reduce the stroke incidence of tbs.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: salt water-perfused catheter, johnson & johnson, usa used with ep shuttle.For reportability purposes this will be coded under unk_smart touch bidirectional sf.Other biosense webster concomitant devices that were also used in this study: 4 pole electrode was placed (johnson & johnson).Lasso electrode, johnson & johnson company, usa).Carto, johnson & johnson, usa).Ep shuttle, johnson & johnson, usa).Non-biosense webster concomitant devices that were also used in this study: 10 pole electrode (st.Jude medical, usa).Long sheath (san jude company, china).Adverse event(s) and provided interventions: 1 case of pericardial effusion.1 case of pulmonary edema.There was no mention of interventions provided.
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