{ "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. 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VISUAL INSPECTION REVEALED THE CONNECTORS AND LABELS APPEARED TO HAVE NO PHYSICAL DAMAGE. THE AMPLIFIER WAS POWERED ON AND PASSED THE POWER ON SELF-TEST (POST) WITH A GREEN LED STATUS. COMMUNICATION WAS ESTABLISHED THE TEST STATION. THE FIELD REPORTED EVENT WAS CONFIRMED AS REVIEW OF ERROR LOGS IDENTIFIED CONSISTENT BOARD SHUTDOWNS TOWARDS CATH AMP BOARD ON SLOT 6. THE ROOT CAUSE WAS ISOLATED TO THE CATH AMP BOARD ON SLOT 6. THE DEVICE HISTORY RECORD WAS REVIEWED TO ENSURE THAT EACH MANUFACTURING AND INSPECTION OPERATION WAS PERFORMED. THE REVIEW DETERMINED THE PROCESS WAS PERFORMED AND COMPLETED IN ACCORDANCE WITH ABBOTT SPECIFICATIONS AND PROCEDURES. BASED ON THE INFORMATION PROVIDED TO ABBOTT AND THE INVESTIGATION PERFORMED, THE ROOT CAUSE WAS ISOLATED TO THE CATH AMP BOARD ON SLOT 6." }, { "mdr_text_key": "189886381", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "THE RESULTS, METHOD, AND CONCLUSION CODES ALONG WITH THE INVESTIGATION WILL BE PROVIDED IN THE FINAL REPORT." }, { "mdr_text_key": "189886382", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "RELATED MANUFACTURER REFERENCE NUMBER: 3005334138-2020-00166. DURING A PULMONARY VEIN ISOLATION ABLATION PROCEDURE, A CARDIAC TAMPONADE OCCURRED. WHEN ABLATION WAS BEING PERFORMED AN AMPLIFIER ERROR OCCURRED, WITH THE STATUS LIGHT CHANGING TO FLASHING ORANGE. IN ADDITION, THE ABLATION CATHETER WAS NO LONGER BEING DISPLAYED. THE AMPLIFIER WAS REPLACED TO RESOLVE THE ISSUE HOWEVER THE PATIENT HAD BECOME HYPOTENSIVE. AN ECHOCARDIOGRAM WAS PERFORMED REVEALING A CARDIAC TAMPONADE, FOR WHICH A PERICARDIOCENTESIS WAS PERFORMED TO STABILIZE THE PATIENT." } ], "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": "05/08/2020" } ] }