{
  "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": "2026-09-08",
    "results": {
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      "manufacturer_contact_zip_ext": "",
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      "date_of_event": "20201103",
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          "generic_name": "COMPUTER-ASSISTED SURGICAL DEVICE",
          "manufacturer_d_name": "MEDTECH SA",
          "manufacturer_d_address_1": "ZAC EUREKA",
          "manufacturer_d_address_2": "900 RUE DU MAS DE VERCHANT",
          "manufacturer_d_city": "MONTPELLIER, LANGUEDOC-ROUSSILLON",
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          "combination_product_flag": "N",
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          "openfda": {
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        "Computer Software Problem"
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      "suppl_dates_mfr_received": "01/29/2021",
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      "manufacturer_contact_country": "",
      "date_changed": "20250806",
      "health_professional": "",
      "summary_report_flag": "N",
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      "manufacturer_contact_phone_number": "",
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          "date_received": "20201125",
          "sequence_number_treatment": [
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          ],
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          "patient_age": "",
          "patient_sex": "",
          "patient_weight": "",
          "patient_ethnicity": "",
          "patient_race": "",
          "patient_problems": [
            "No Code Available",
            "No Code Available"
          ]
        }
      ],
      "distributor_city": "",
      "date_report": "20210202",
      "initial_report_to_fda": "",
      "distributor_state": "",
      "event_key": "",
      "manufacturer_g1_country": "",
      "manufacturer_contact_city": "",
      "mdr_report_key": "10906054",
      "removal_correction_number": "N/A",
      "number_devices_in_event": "",
      "date_manufacturer_received": "20201112",
      "manufacturer_name": "",
      "report_source_code": "Manufacturer report",
      "remedial_action": [
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      ],
      "manufacturer_g1_zip_code": "",
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      "manufacturer_g1_name": "",
      "adverse_event_flag": "Y",
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      "manufacturer_postal_code": "",
      "single_use_flag": "",
      "manufacturer_country": "",
      "mdr_text": [
        {
          "mdr_text_key": "321963560",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "0",
          "text": "DHR REVIEW AND REVIEW OF COMPLAINT HISTORY DID NOT IDENTIFY ANY CONTRIBUTORY FACTORS TO THE EVENT. A FULL ANALYSIS OF THE DATA LOGS HAS BEEN PERFORMED AND CONCLUDED THAT ALTHOUGH THE USER DID NOT FOLLOW ALL THE RECOMMANDATIONS OF VERIFICATION, THE REGISTRATION WAS ACCURATE. THE PLACEMENT OF IMPLANTS AT THE ENTRY POINTS ARE ACCURATE BUT NOT IN DEPTH AT THE TARGET POINTS. HOWEVER, THE ACCURACY IN DEPTH DEPENDS ON THE METHOD OF IMPLANTATION. IN THIS CASE, THE ELEMENTS OF ANALYSIS INDICATE THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS."
        },
        {
          "mdr_text_key": "321963561",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "0",
          "text": "THE SURGEON NOTIFIED THE CLINICAL REPRESENTATIVE (CR) THAT ONE OF RNS LEADS IMPLANTED WAS TOO DEEP BY APPROXIMATELY 12 MM. A REVISION SURGERY WAS PERFORMED, AND SURGEON CONFIRMED THAT MEASUREMENT MARK ON ELECTRODE WAS IN CORRECT SPOT. NO KNOWN COMPLICATIONS FOR THE PATIENT."
        },
        {
          "mdr_text_key": "218573257",
          "text_type_code": "Additional Manufacturer Narrative",
          "patient_sequence_number": "1",
          "text": "THE DEVICE HAS NOT BEEN EVALUATED YET FOR INVESTIGATION PURPOSE. ONCE THE EVALUATION IS PERFORMED, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED. UNIQUE IDENTIFIER (UDI) #: (B)(4)."
        },
        {
          "mdr_text_key": "218573258",
          "text_type_code": "Description of Event or Problem",
          "patient_sequence_number": "1",
          "text": "THE SURGEON NOTIFIED THE CLINICAL REPRESENTATIVE (CR) THAT ONE OF RNS LEADS IMPLANTED WAS TOO DEEP BY APPROXIMATELY 12 MM. A REVISION SURGERY WAS PERFORMED, AND SURGEON CONFIRMED THAT MEASUREMENT MARK ON ELECTRODE WAS IN CORRECT SPOT. NO KNOWN COMPLICATIONS FOR THE PATIENT."
        }
      ],
      "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": "02/02/2021"
    }
  ]
}