{
  "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": "2026-09-29",
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      "manufacturer_contact_zip_ext": "",
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          "date_removed_year": "2021",
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          "brand_name": "PROCLAIM¿ 5 ELITE IMPLANTABLE PULSE GENERATOR",
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          "device_report_product_code": "LGW",
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            "medical_specialty_description": "Unknown",
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      ],
      "reporter_state_code": "CA",
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      "mfr_report_type": "Thirty-Day",
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          "sequence_number_outcome": [
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          "patient_age": "NA",
          "patient_sex": "Female",
          "patient_weight": "66 KG",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "Hematoma",
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      ],
      "distributor_city": "",
      "date_report": "20260602",
      "initial_report_to_fda": "No",
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      "manufacturer_g1_country": "US",
      "manufacturer_contact_city": "PLANO",
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      "removal_correction_number": "",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20260511",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
        ""
      ],
      "manufacturer_g1_zip_code": "00612",
      "report_to_manufacturer": "",
      "manufacturer_zip_code_ext": "",
      "manufacturer_g1_name": "ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC)",
      "adverse_event_flag": "Y",
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      "single_use_flag": "Y",
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      "mdr_text": [
        {
          "mdr_text_key": "403114264",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "IT WAS REPORTED FOLLOWING THE IMPLANT PROCEDURE PATIENT EXPERIENCED BLOT CLOT IN THEIR LEFT LEG AND MUSCLE SPASMS. AS A RESULT, SURGICAL INTERVENTION WAS UNDERTAKEN WHEREIN THE ENTIRE SYSTEM WAS EXPLANTED TO ADDRESS THE ISSUE."
        },
        {
          "mdr_text_key": "403114265",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "DATE OF EVENT IS ESTIMATED. BASED ON THE INFORMATION PROVIDED A DEVICE PROBLEM WAS NOT IDENTIFIED, AS A RESULT A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED."
        }
      ],
      "number_patients_in_event": "",
      "distributor_name": "",
      "manufacturer_g1_address_1": "LOT A INTERIOR - #2 STREET KM 67.5",
      "distributor_zip_code": "",
      "manufacturer_contact_postal_code": "75024",
      "manufacturer_contact_exchange": "",
      "manufacturer_contact_pcountry": "",
      "suppl_dates_fda_received": ""
    }
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}