{ "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": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "", "report_to_fda": "N", "manufacturer_contact_t_name": "Ms.", "manufacturer_contact_state": "IN", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "Mauguio, Languedoc-Roussillon", "manufacturer_contact_address_1": "56 E. 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G2: FOREIGN - EVENT OCCURRED IN JAPAN. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED." }, { "mdr_text_key": "395320875", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "IT WAS REPORTED THAT IMAGING OBTAINED IMMEDIATELY AFTER DEEP ELECTRODE PLACEMENT SUGGESTED A MILD EPIDURAL HEMATOMA, AND THE PATIENT WAS MANAGED WITH OBSERVATION. DURING THE PROCEDURE, THE ELECTRODE INSERTED INTO THE INSULA ON THE SECOND TRAJECTORY WAS REPLACED AFTER A BREAK IN THE ELECTRODE WIRE WAS CONFIRMED, AND THE PHYSICIAN INDICATED THAT THE REPLACEMENT MAY HAVE CONTRIBUTED TO THE HEMATOMA. A FOLLOW-UP CT SCAN OBTAINED APPROXIMATELY SEVERAL HOURS LATER SHOWED NO ENLARGEMENT OF THE HEMATOMA, AND THE PATIENT REMAINED CONSCIOUS. THE PATIENT WAS MONITORED WITHOUT THERAPEUTIC INTERVENTION. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED." } ], "number_patients_in_event": "", "distributor_name": "", "manufacturer_g1_address_1": "432 Rue du Rajol", "distributor_zip_code": "", "manufacturer_contact_postal_code": "46582", "manufacturer_contact_exchange": "", "manufacturer_contact_pcountry": "", "suppl_dates_fda_received": "08/26/2026" } ] }