{
  "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": "2026-09-08",
    "results": {
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  },
  "results": [
    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
      "event_location": "",
      "report_to_fda": "",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "OR",
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      "manufacturer_contact_address_1": "6024 Jean Road",
      "manufacturer_contact_pcity": "+1(877)2",
      "event_type": "Injury",
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        "Followup"
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      "date_received": "20260731",
      "manufacturer_address_2": "",
      "pma_pmn_number": "P070008",
      "date_of_event": "20260714",
      "reprocessed_and_reused_flag": "N",
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      "manufacturer_contact_zip_code": "97035",
      "reporter_occupation_code": "PHYSICIAN",
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      "distributor_zip_code_ext": "",
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      "manufacturer_g1_state": "",
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      "manufacturer_contact_area_code": "",
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      "device_date_of_manufacturer": "20240806",
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        {
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          "date_removed_flag": "",
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          "brand_name": "Sentus ProMRI OTW QP L-85/49",
          "generic_name": "LV lead",
          "manufacturer_d_name": "Biotronik SE & Co. KG",
          "manufacturer_d_address_1": "Woermannkehre 1",
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          "other_id_number": "",
          "device_availability": "No",
          "device_report_product_code": "OJX",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "N",
          "combination_product_flag": "Y",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "device_name": "Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode",
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        }
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      ],
      "reporter_state_code": "CA",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "08/03/2026",
      "mfr_report_type": "Thirty-Day",
      "manufacturer_contact_country": "US",
      "date_changed": "20260813",
      "health_professional": "N",
      "summary_report_flag": "N",
      "manufacturer_g1_zip_code_ext": "",
      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
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      "patient": [
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          "date_received": "20260731",
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            ""
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            " R"
          ],
          "patient_age": "",
          "patient_sex": "Male",
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          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260803",
      "initial_report_to_fda": "No",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "Lake Oswego",
      "mdr_report_key": "50094082",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260714",
      "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",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "Y",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "15858099302",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "Combination Product: YES.Biotronik submits this report to comply with FDA regulations 21 CFR parts 4 and 803. Biotronik has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report. This report does not constitute an admission or a conclusion by Biotronik, or its employees that the device, Biotronik, or its employee caused or contributed to the event described in the report. Any required fields that are unpopulated are blank because the information is currently unknown or unavailable. Biotronik will submit a supplemental report if additional relevant information becomes known."
        },
        {
          "mdr_text_key": "15358099298",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "Lead was explanted due to fracture. No adverse patient events were reported. Should additional information be received, this file will be updated."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "97035",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": "08/04/2026"
    }
  ]
}