{
  "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": "2026-06-30",
    "results": {
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      "manufacturer_contact_zip_ext": "4391",
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      "manufacturer_contact_t_name": "",
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          "device_evaluated_by_manufacturer": "*",
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      "suppl_dates_mfr_received": "",
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          "sequence_number_treatment": [
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          "patient_age": "NA",
          "patient_sex": "Male",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
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          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20260506",
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      "distributor_state": "",
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      "manufacturer_g1_country": "SN",
      "manufacturer_contact_city": "MOUNDS VIEW",
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      "number_devices_in_event": "",
      "date_manufacturer_received": "20260423",
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      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "48605",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "MEDTRONIC SINGAPORE OPERATIONS",
      "adverse_event_flag": "N",
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      "manufacturer_state": "",
      "distributor_address_2": "",
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      "single_use_flag": "Y",
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      "mdr_text": [
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          "mdr_text_key": "400738539",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED THAT TRUE PAUSE EPISODES WERE REJECTED AS FALSE BY THE ARTIFICIAL INTELLIGENCE (AI) ALGORITHM. IT WAS FURTHER REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR (ICM) DETECTED FALSE VENTRICULAR TACHYCARDIA (VT) EPISODES. THE ICM REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT."
        },
        {
          "mdr_text_key": "400738540",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC 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 FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "49 CHANGI SOUTH AVENUE 2",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "551124391",
      "manufacturer_contact_exchange": "763",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}