{
  "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": "2026-09-29",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 17750
    }
  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
      "manufacturer_contact_address_2": "",
      "manufacturer_g1_city": "SALUGGIA (VC)",
      "manufacturer_contact_address_1": "VIA CRESCENTINO S.N",
      "manufacturer_contact_pcity": "14601308",
      "event_type": "Malfunction",
      "report_number": "1000165971-2026-00293",
      "type_of_report": [
        "Initial submission",
        "Followup"
      ],
      "product_problem_flag": "Y",
      "date_received": "20260603",
      "manufacturer_address_2": "",
      "pma_pmn_number": "P980049",
      "date_of_event": "20260507",
      "reprocessed_and_reused_flag": "",
      "manufacturer_address_1": "",
      "exemption_number": "",
      "manufacturer_contact_zip_code": "13040",
      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "146013082",
      "noe_summarized": "1",
      "manufacturer_contact_l_name": "ROUSSEAU-PLASSE",
      "source_type": [
        "Company representation"
      ],
      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "13040",
      "manufacturer_g1_state": "",
      "reporter_country_code": "FR",
      "manufacturer_contact_area_code": "",
      "date_added": "20260603",
      "manufacturer_contact_f_name": "ANNE",
      "previous_use_code": "I",
      "device": [
        {
          "device_event_key": "",
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          "date_removed_flag": "",
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          "implant_date_year": "",
          "date_removed_year": "",
          "serviced_by_3rd_party_flag": "N",
          "date_received": "20260603",
          "brand_name": "CPR4",
          "generic_name": "PACEMAKER/ICD/CRT NON-IMPLANTED COMPONENTS",
          "manufacturer_d_name": "MICROPORT CRM S.R.L.",
          "manufacturer_d_address_1": "VIA CRESCENTINO S.N",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SALUGGIA (VC)",
          "manufacturer_d_state": "",
          "manufacturer_d_zip_code": "13040",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "IT",
          "manufacturer_d_postal_code": "13040",
          "device_operator": "HEALTH PROFESSIONAL",
          "model_number": "CPR4 HEAD",
          "catalog_number": "",
          "lot_number": "",
          "other_id_number": "",
          "device_availability": "Device was returned to manufacturer",
          "date_returned_to_manufacturer": "20260602",
          "device_report_product_code": "OSR",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "Y",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Pacemaker/Icd/Crt Non-Implanted Components",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
          }
        }
      ],
      "product_problems": [
        "Communication or Transmission Problem"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "*",
      "mfr_report_type": "Follow-Up",
      "manufacturer_contact_country": "IT",
      "date_changed": "20260812",
      "health_professional": "Y",
      "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": "20260603",
          "sequence_number_treatment": [
            ""
          ],
          "sequence_number_outcome": [
            ""
          ],
          "patient_age": "NA",
          "patient_sex": "Unknown",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Clinical Signs, Symptoms or Conditions"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260722",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "IT",
      "manufacturer_contact_city": "SALUGGIA (VC)",
      "mdr_report_key": "25370215",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "13040",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "MICROPORT CRM S.R.L.",
      "adverse_event_flag": "N",
      "distributor_address_1": "",
      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "Y",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "403743111",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "ANALYSIS OF THE RETURNED SUBJECT DEVICE DID NOT PERMIT TO REPRODUCE THE REPORTED EVENT AS THE TELEMETRY HEAD IS WORKING NORMALLY. REVIEW OF THE PROVIDED FILES IS STILL ONGOING, RESULTS WILL BE PROVIDED ON THE NEXT REPORT."
        },
        {
          "mdr_text_key": "403743112",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "REPORTEDLY, ON 7-MAY-2026, IT IS NOT POSSIBLE TO ESTABLISH TELEMETRY COMMUNICATION WITH THE CPR4 HEAD. USING A CPR3 HEAD RESOLVED THE ISSUE."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "VIA CRESCENTINO S.N",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "13040",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "33",
      "suppl_dates_fda_received": "07/22/2026"
    }
  ]
}