{
  "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": "2026-07-07",
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      "manufacturer_contact_zip_ext": "",
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      "event_location": "I",
      "report_to_fda": "*",
      "manufacturer_contact_t_name": "",
      "manufacturer_contact_state": "",
      "manufacturer_link_flag": "Y",
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      "manufacturer_contact_address_1": "",
      "manufacturer_contact_pcity": "",
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      "type_of_report": [
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        "Followup"
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      "pma_pmn_number": "P890003",
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      "reprocessed_and_reused_flag": "N",
      "manufacturer_address_1": "",
      "exemption_number": "",
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      "reporter_occupation_code": "PHYSICIAN",
      "manufacturer_contact_plocal": "",
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      "manufacturer_g1_state": "",
      "reporter_country_code": "IT",
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      "date_added": "20200427",
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      "device": [
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          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
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          "date_removed_year": "",
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          "brand_name": "CARELINK PROGRAMMER",
          "generic_name": "PROGRAMMER, PACEMAKER",
          "manufacturer_d_name": "MEDTRONIC, INC.",
          "manufacturer_d_address_1": "8200 CORAL SEA STREET NE",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "MOUNDS VIEW",
          "manufacturer_d_state": "MN",
          "manufacturer_d_zip_code": "55112",
          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "55112",
          "device_operator": "0",
          "model_number": "2090W",
          "catalog_number": "2090W",
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          "device_report_product_code": "KRG",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
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            "fei_number": [
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            "device_name": "Programmer, Pacemaker",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.3700",
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        }
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      "product_problems": [
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        "Failure to Calibrate",
        "Electrical /Electronic Property Problem",
        "Failure to Calibrate"
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      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "06/03/2020",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250728",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_extension": "",
      "manufacturer_city": "",
      "manufacturer_contact_phone_number": "",
      "patient": [
        {
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          "date_received": "20200427",
          "sequence_number_treatment": [
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          "sequence_number_outcome": [
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          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Patient Involvement",
            "No Patient Involvement"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200629",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000142",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200401",
      "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": "189709802",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED."
        },
        {
          "mdr_text_key": "189709843",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT PRIOR TO THE FOLLOW UP SESSION THE PROGRAMMER DID NOT RECOGNISE THE ANALYSER. THERE WAS NO DELAY IN PROCEDURE. THE PROGRAMMER WILL BE RETURNED TO SERVICE AND REPAIR. THERE WAS NO PATIENT INVOLVEMENT."
        },
        {
          "mdr_text_key": "201362667",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "PRODUCT ANALYSIS: THE ANALYSIS COULD NOT CONFIRM THE CUSTOMER COMMENT OF THE PROGRAMMER DID NOT RECOGNISE THE ANALYSER. THE ANALYSER PASSED ALL FUNCTIONAL INCOMING TESTS. IT WAS ALSO DETERMINED AT ANALYSIS THAT THE CORD BAY LATCHES WERE BROKEN, THE UPPER LEFT AND RIGHT ASSEMBLY HINGES WERE WORN. THE RADIO FREQUENCY (RF) HEAD CABLE IS WORN OUT BUT FUNCTIONAL, THE ANTI-SLIP LAYER FOR THE RF HEAD WAS RIPPED OFF. THE PAPER TRAY WAS NEARLY EMPTY, AND THE LOWER RIGHT BULLET ASSAY WAS BROKEN. ALL FOUND DEFECTIVE PARTS WERE REPLACED AND ALL OTHER IDENTIFIED ISSUES WERE RESOLVED. THE DEVICE THEN PASSED ALL FINAL FUNCTIONAL TESTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED."
        },
        {
          "mdr_text_key": "201362668",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS FURTHER REPORTED THE PROGRAMMER RETURNED TO SERVICE AND REPAIR."
        }
      ],
      "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": "06/29/2020"
    }
  ]
}