B2.Date of death - the exact date of death is unknown at this time and so this field was populated with 28-sep-2023 which is the date of the drra report submission.Section d4: the catalog for this is unk_smart touch bidirectional sf.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Device history record (dhr) review 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.Biosense webster manufacturer's reference number (b)(4) has five reports: (1) mdr # for id (b)(6) experienced complete heart block (heart block av) and (pulmonary edema) within 7 days of index ablation procedure.This patient also died within 88 days of the safety evaluation period but the cause of death information is not available.(2) mfr # 2029046-2023-02441 for id (b)(6) experienced cardiac tamponade/perforation (cardiac tamponade) requiring pericardiocentesis (recognized procedural complication) within 30 days of index ablation procedure.(3) mfr # 2029046-2023-02442 for id (b)(6) experienced cardiac tamponade/perforation (cardiac tamponade) requiring pericardiocentesis (recognized procedural complication) within 30 days of index ablation procedure.(4) mfr # 2029046-2023-02443 for id (b)(6) experienced cardiac tamponade/perforation (cardiac tamponade) requiring pericardiocentesis (recognized procedural complication) within 30 days of index ablation procedure.(5) mfr # 2029046-2023-02444 for id (b)(6) experienced atrio-ventricular block, second degree (heart block) and acute pulmonary edema (pulmonary edema) within 7 days of index ablation procedure.
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