{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-05", "results": { "skip": 0, "limit": 1, "total": 40656 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "N", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3008452825-2020-00214", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "K061363", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "FOREIGN", "LITERATURE" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "GM", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "464716", "implant_date_year": "", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "AGILIS¿ INTRODUCER, UNKNOWN", "generic_name": "INTRODUCER, CATHETER", "manufacturer_d_name": "ST. JUDE MEDICAL, COSTA RICA LTDA", "manufacturer_d_address_1": "PARQUE INDUSTRIAL, ZONA FRANCA COYOL S.A.", "manufacturer_d_address_2": "EDIFICIO #44B, CALLE 0, AVENIDA 2, COYOL", "manufacturer_d_city": "ALAJUELA, COSTA RICA", "manufacturer_d_state": "", "manufacturer_d_zip_code": "1897-", "manufacturer_d_zip_code_ext": "4050", "manufacturer_d_country": "CS", "manufacturer_d_postal_code": "1897-4050", "device_operator": "HEALTH PROFESSIONAL", "model_number": "", "catalog_number": "", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "DYB", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "", "udi_public": "", "openfda": { "registration_number": [ "3008452825" ], "fei_number": [ "3008452825" ], "device_name": "Introducer, Catheter", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.1340", "device_class": "2" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250818", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Other" ], "patient_age": "", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Cardiac Perforation", "Cardiac Perforation" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000578", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200406", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189913839", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS NOT REVIEWED AS THE BATCH NUMBER WAS NOT AVAILABLE. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED PERICARDIAL EFFUSION COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC PERFORATION IS A KNOWN RISK DURING THE USE OF THIS DEVICE." }, { "mdr_text_key": "189913840", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "RELATED MANUFACTURING REFERENCE: 3005334138-2020-00168. THE FOLLOWING WAS PUBLISHED IN EUROPACE IN AN ARTICLE TITLED \"SAFETY AND OUTCOME OF VERY HIGH-POWER SHORT-DURATION ABLATION USING 70 W FOR PULMONARY VEIN ISOLATION IN PATIENTS WITH PAROXYSMAL ATRIA FIBRILLATION\" BY M KOTTMAIER ET AL., 2020; 22: 388-393. DOI: 10.1093/EUROPACE/EUZ342. THE AIM OF THIS STUDY WAS TO COMPARE INTRAPROCEDURAL SAFETY AND OUTCOME OF HIGH-POWER SHORT-DURATION (HPSD) ABLATION TO CONVENTIONAL POWER SETTINGS IN PATIENTS UNDERGOING PULMONARY VEIN ISOLATION (PVI) FOR PAROXYSMAL ATRIAL FIBRILLATION (PAF). THERE WERE 197 PATIENTS WITH PAF SCHEDULED FOR PVI ENROLLED IN THE STUDY. AN ABLATION WITH 70 W AND A DURATION CUT-OFF OF 7 SECONDS AT THE ANTERIOR LEFT ATRIUM (LA) AND 5 SECONDS AT THE POSTERIOR LA WAS COMPARED TO CONVENTIONAL POWER PROTOCOL WITH 30-40 W FOR 20-40 SECONDS. THE STUDY SHOWED THAT IN A 1-YEAR OUTCOME THE HPSD GROUP SHOWED SIGNIFICANTLY LESS ARRHYTHMIA RECURRENCE (83.1%) COMPARED TO 65.1% IN THE STANDARD GROUP. OF THE 197 PATIENTS THERE WERE A TOTAL OF 5 PERICARDIAL EFFUSIONS > 5MM WITHOUT TAMPONADE." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "", "distributor_zip_code": "", "manufacturer_contact_postal_code": "", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "" } ] }