(b)(4).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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The following manufacturer report numbers: 2029046-2020-01606 2029046-2020-01607 2029046-2020-01609 2029046-2020-01610 2029046-2020-01611 2029046-2020-01612 2029046-2020-01613 2029046-2020-01614 2029046-2020-01615 2029046-2020-01616 2029046-2020-01617 are related to the same incident.
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This complaint is from a literature source.The following complications were reported in this publication: major immediate less than or equal to 4 hours post operation: it was reported that 1 patient underwent ablation aided by 3d mapping and point by point ablation with the pentaray and suffered cardiac tamponade.Intervention required a drain.Other biosense webster devices that were also used in this study: carto non-biosense webster devices that were also used in this study: velocity/precision with optima, hd-grid mapping catheter publication details title: safety and cost-effectiveness of same-day complex left atrial ablation objective: catheter ablation for complex left-atrial arrhythmia is increasing worldwide with many centres admitting patients overnight.Same-day procedures using conscious sedation carry significant benefits to patients/healthcare providers but data are limited.We evaluated the safety and cost-effectiveness of same-day complex left-atrial arrhythmia ablation.Methods: multi-centre retrospective cohort study of all consecutive complex elective left-atrial ablation procedures performed between january 2011 and december 2019.Data were collected on planned same-day discharge versus overnight stay, baseline parameters, procedure details/success, ablation technology, post-operative complications, unplanned overnight admissions/outcomes at 4-months and mortality up to april 2020.A cost analysis of potential savings was also performed.
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