{
  "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",
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    {
      "manufacturer_contact_zip_ext": "",
      "manufacturer_g1_address_2": "",
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      "report_to_fda": "N",
      "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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        "Followup"
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      "pma_pmn_number": "P950029",
      "date_of_event": "20200409",
      "reprocessed_and_reused_flag": "N",
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      "exemption_number": "",
      "manufacturer_contact_zip_code": "",
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      "manufacturer_contact_plocal": "",
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      "distributor_zip_code_ext": "",
      "manufacturer_g1_postal_code": "",
      "date_facility_aware": "20200410",
      "manufacturer_g1_state": "",
      "reporter_country_code": "JA",
      "manufacturer_contact_area_code": "",
      "date_added": "20200428",
      "manufacturer_contact_f_name": "",
      "previous_use_code": "",
      "device": [
        {
          "device_event_key": "",
          "implant_flag": "",
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          "implant_date_year": "2011",
          "date_removed_year": "2020",
          "serviced_by_3rd_party_flag": "",
          "date_received": "20200428",
          "brand_name": "REPLY",
          "generic_name": "PULSE GENERATOR, PERMANENT, IMPLANTABLE",
          "manufacturer_d_name": "SORIN GROUP ITALIA S.R.L. - CRM FACILITY",
          "manufacturer_d_address_1": "PARC D'AFFAIRES NOVEOS 4 AVENUE RÉAUMUR",
          "manufacturer_d_address_2": ".",
          "manufacturer_d_city": "CLAMART",
          "manufacturer_d_state": "",
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          "manufacturer_d_zip_code_ext": "",
          "manufacturer_d_country": "FR",
          "manufacturer_d_postal_code": "92140",
          "device_operator": "HEALTH PROFESSIONAL",
          "expiration_date_of_device": "20120209",
          "model_number": "REPLY SR",
          "catalog_number": "REPLY SR",
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          "other_id_number": "",
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          "date_returned_to_manufacturer": "20200617",
          "device_report_product_code": "DXY",
          "device_age_text": "DA",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
          "udi_di": "",
          "udi_public": "",
          "openfda": {
            "registration_number": [
              "1000165971"
            ],
            "fei_number": [
              "1000165971"
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            "device_name": "Implantable Pacemaker Pulse-Generator",
            "medical_specialty_description": "Cardiovascular",
            "regulation_number": "870.3610",
            "device_class": "3"
          }
        }
      ],
      "product_problems": [
        "Disconnection",
        "Disconnection"
      ],
      "reporter_state_code": "",
      "manufacturer_zip_code": "",
      "suppl_dates_mfr_received": "06/25/2020",
      "mfr_report_type": "",
      "manufacturer_contact_country": "",
      "date_changed": "20250727",
      "health_professional": "",
      "summary_report_flag": "N",
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      "patient": [
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          "date_received": "20200428",
          "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 Consequences Or Impact To Patient",
            "No Consequences Or Impact To Patient"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200720",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10006108",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200410",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "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": "189447920",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "A PACEMAKER REPLACEMENT PROCEDURE DUE TO NORMAL BATTERY DEPLETION WAS CONDUCTED. AFTER THE SUBJECT PACEMAKER WAS EXPLANTED, THE PHYSICIAN ATTEMPTED TO REMOVE THE LEAD CONNECTOR WITH THE SCREWDRIVER, BUT IT REPORTEDLY DID NOT WORK CORRECTLY. THE SCREWDRIVER WAS REPLACED AND ANOTHER ATTEMPT TO DISCONNECT THE LEAD WAS MADE, BUT ACCORDING TO THE PHYSICIAN, IT DIDN'T FEEL LIKE THE SCREWDRIVER WAS INSERTED INTO THE SETSCREW, AFTER TURNING THE SCREWDRIVER A FEW TIMES, THE LEAD COULD BE PULLED OUT."
        },
        {
          "mdr_text_key": "319899297",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "PLEASE REFER TO THE ATTACHED ANALYSIS REPORT."
        },
        {
          "mdr_text_key": "319899298",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "A PACEMAKER REPLACEMENT PROCEDURE DUE TO NORMAL BATTERY DEPLETION WAS CONDUCTED.AFTER THE SUBJECT PACEMAKER WAS EXPLANTED, THE PHYSICIAN ATTEMPTED TO REMOVE THE LEAD CONNECTOR WITH THE SCREWDRIVER, BUT IT REPORTEDLY DID NOT WORK CORRECTLY. THE SCREWDRIVER WAS REPLACED AND ANOTHER ATTEMPT TO DISCONNECT THE LEAD WAS MADE, BUT ACCORDING TO THE PHYSICIAN, IT DIDN'T FEEL LIKE THE SCREWDRIVER WAS INSERTED INTO THE SETSCREW. ,AFTER TURNING THE SCREWDRIVER A FEW TIMES, THE LEAD COULD BE PULLED OUT."
        }
      ],
      "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": "07/20/2020"
    }
  ]
}