{
  "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": "2026-10-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 216
    }
  },
  "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": "Malfunction",
      "report_number": "2184149-2021-00081",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20210329",
      "manufacturer_address_2": "",
      "pma_pmn_number": "",
      "date_of_event": "20210305",
      "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": [
        "COMPANY REPRESENTATIVE",
        "HEALTH"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
      "manufacturer_contact_area_code": "",
      "date_added": "20210329",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "477912",
          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "U",
          "date_received": "20210329",
          "brand_name": "ENSITE X  EP SYSTEM",
          "generic_name": "COMPUTER, DIAGNOSTIC, PROGRAMMABLE",
          "manufacturer_d_name": "ST. JUDE MEDICAL",
          "manufacturer_d_address_1": "ONE ST. JUDE MEDICAL DRIVE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "ST. PAUL",
          "manufacturer_d_state": "MN",
          "manufacturer_d_zip_code": "55117",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "55117",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "ENSITE-SYSTEM-01",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "DQK",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Computer, Diagnostic, Programmable",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.1425",
            "device_class": "2"
          }
        }
      ],
      "product_problems": [
        "Communication or Transmission Problem",
        "Communication or Transmission Problem"
      ],
      "reporter_state_code": "MA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "04/14/2021",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250731",
      "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": "20210329",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions",
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20210416",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "11580939",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20210305",
      "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": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "242680200",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "DURING THE PROCEDURE, AFTER SWITCHING FROM NAVX TO VOXEL MODE, THE CONTACT FORCE CATHETER WOULD NOT DISPLAY CONTACT FORCE. THE CATHETER WAS UNPLUGGED AND RE-PLUGGED INTO THE SYSTEM, AND THE TACTISYS WAS DISCONNECTED AND RE-CONNECTED BUT THE ISSUE PERSISTED. THE PROCEDURE WAS CANCELLED DUE TO THIS ISSUE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES."
        },
        {
          "mdr_text_key": "323949186",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED AND NO LOG FILES/CASE STUDY WAS PROVIDED.  BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT REMAINS UNKNOWN."
        }
      ],
      "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": "04/16/2021"
    }
  ]
}