{
  "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": {
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          "manufacturer_d_address_2": "",
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          "manufacturer_d_state": "",
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          "manufacturer_d_zip_code_ext": "",
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            "medical_specialty_description": "Cardiovascular",
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        }
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      "product_problems": [
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      "reporter_state_code": "AZ",
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      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "",
      "date_changed": "20250817",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
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      "patient": [
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          "sequence_number_treatment": [
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      "manufacturer_contact_city": "",
      "mdr_report_key": "1000035",
      "removal_correction_number": "NA",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20080201",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
      "report_to_manufacturer": "",
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      "mdr_text": [
        {
          "mdr_text_key": "18206392",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THIS PRODUCT IS AVAILABLE; HOWEVER, IT HAS NOT BEEN RECEIVED FOR ANALYSIS. ADD'L INFO WILL BE PROVIDED WITHIN 30 DAYS OF RECEIPT."
        },
        {
          "mdr_text_key": "18240065",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "DURING THE PROCEDURE, THE TIP OF THE OUTBACK BROKE AND SEPARATED INSIDE THE PT. THE PHYSICIAN WAS UNABLE TO RETRIEVE THE DEVICE. IT WAS FELT THAT IT WOULD NOT HARM THE PT; THEREFORE, IT WAS NOT REMOVED. THERE WERE NO COMPLICATIONS TO THE PT. THE LESION WAS STENOSED AND CALCIFIED. THE PRODUCT WILL BE RETURNED FOR ANALYSIS."
        }
      ],
      "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": ""
    }
  ]
}