{
  "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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      "report_number": "2124215-2020-09231",
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      "manufacturer_address_2": "",
      "pma_pmn_number": "P960040/S235",
      "date_of_event": "20200218",
      "reprocessed_and_reused_flag": "I",
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      "exemption_number": "",
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      "reporter_occupation_code": "PHYSICIAN",
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      "manufacturer_g1_state": "",
      "reporter_country_code": "US",
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      "date_added": "20200427",
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          "device_event_key": "",
          "implant_flag": "",
          "date_removed_flag": "",
          "device_sequence_number": "464263",
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          "date_received": "20200427",
          "brand_name": "ENERGEN ICD",
          "generic_name": "IMPLANTABLE DEVICE",
          "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION",
          "manufacturer_d_address_1": "4100 HAMLINE AVENUE NORTH",
          "manufacturer_d_address_2": "",
          "manufacturer_d_city": "SAINT PAUL",
          "manufacturer_d_state": "MN",
          "manufacturer_d_zip_code": "55112",
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          "manufacturer_d_country": "US",
          "manufacturer_d_postal_code": "55112",
          "device_operator": "LAY USER/PATIENT",
          "expiration_date_of_device": "20130930",
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          "device_availability": "Device was returned to manufacturer",
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          "device_report_product_code": "LWP",
          "device_age_text": "",
          "device_evaluated_by_manufacturer": "",
          "combination_product_flag": "N",
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          "openfda": {
            "registration_number": [
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            "device_name": "Implantable Pulse Generator, Pacemaker (Non-Crt)",
            "medical_specialty_description": "Unknown",
            "regulation_number": "",
            "device_class": "3"
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        "Premature Discharge of Battery",
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      "reporter_state_code": "IN",
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      "suppl_dates_mfr_received": "",
      "mfr_report_type": "Initial",
      "manufacturer_contact_country": "",
      "date_changed": "20250728",
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      "summary_report_flag": "N",
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          "patient_sequence_number": "1",
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          "sequence_number_treatment": [
            ""
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          "sequence_number_outcome": [
            "Hospitalization",
            " R"
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          "patient_age": "45 YR",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20200427",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10000634",
      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20200225",
      "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": "Y",
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      "manufacturer_state": "",
      "distributor_address_2": "",
      "manufacturer_postal_code": "",
      "single_use_flag": "",
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      "mdr_text": [
        {
          "mdr_text_key": "189023480",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "(B)(4). THE RETURNED ENERGEN ICD WAS ANALYZED AND A REVIEW OF THE DEVICE MEMORY CONFIRMED THAT A LOW VOLTAGE ALERT, CODE 1003, WAS RECORDED. THE BATTERY VOLTAGE WAS LOWER THAN EXPECTED, BUT STILL SUPPORTED FULL DEVICE FUNCTION. USING HISTORICAL DAILY BATTERY VOLTAGE MEASUREMENT DATA, ENGINEERS DETERMINED THAT THIS DEVICE WAS DEMONSTRATING BEHAVIOR CONSISTENT WITH A HIGH CURRENT CONDITION ASSOCIATED WITH A COMPROMISED LOW VOLTAGE CAPACITOR CONNECTED TO THE DEVICE'S BATTERY. LOW VOLTAGE CAPACITORS ARE USED IN THE DEVICE'S HIGH VOLTAGE CHARGING OPERATION IN ORDER TO FACILITATE FAST CHARGE TIMES. MALFUNCTION OF THESE CAPACITORS RESULTED IN A HIGH CURRENT DRAIN, WHICH WAS DEPLETING THIS DEVICE'S BATTERY FASTER THAN NORMAL. BOSTON SCIENTIFIC HAS ISSUED AN ADVISORY COMMUNICATION REGARDING AN OLDER SUBSET OF COGNIS/TELIGEN DEVICES THAT IS MORE SUSCEPTIBLE TO THIS ANOMALY. SPECIFICALLY, THE PERFORMANCE OF A LOW VOLTAGE CAPACITOR MAY BE COMPROMISED OVER TIME, CAUSING AN INCREASED CURRENT DRAIN THAT CAN LEAD TO PREMATURE BATTERY DEPLETION. THIS PARTICULAR DEVICE WAS NOT INCLUDED IN THE ADVISORY POPULATION."
        },
        {
          "mdr_text_key": "189023481",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "IT WAS REPORTED THAT THE PACEMAKER WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. NO ADDITIONAL ADVERSE PATIENT ISSUES WERE REPORTED."
        }
      ],
      "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": ""
    }
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}