{ "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. 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THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FIBROMYALGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), IDIOPATHIC INTRACRANIAL HYPERTENSION (\"INTRAPATHIC INTRACRANINAL HYPERTENSION(IIH)\"), OSTEOARTHRITIS (\"DEGENERATIVE JOINT DISEASE (DJD)\") AND INTERVERTEBRAL DISC DEGENERATION (\"DEGENERATIVE DISC DISEASE(DDD)\"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FIBROMYALGIA, IDIOPATHIC INTRACRANIAL HYPERTENSION, OSTEOARTHRITIS AND INTERVERTEBRAL DISC DEGENERATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FIBROMYALGIA, IDIOPATHIC INTRACRANIAL HYPERTENSION, INTERVERTEBRAL DISC DEGENERATION AND OSTEOARTHRITIS TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT." }, { "mdr_text_key": "316584506", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS SPONTANEOUS CASE WAS REPORTED BY A LAWYER AND DESCRIBES THE OCCURRENCE OF FIBROMYALGIA ('I HAVE FIBROMYALGIA') IN A FEMALE PATIENT WHO HAD ESSURE INSERTED. THE OCCURRENCE OF ADDITIONAL NON-SERIOUS EVENTS IS DETAILED BELOW. ON AN UNKNOWN DATE, THE PATIENT HAD ESSURE INSERTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED FIBROMYALGIA (SERIOUSNESS CRITERIA MEDICALLY SIGNIFICANT AND INTERVENTION REQUIRED), IDIOPATHIC INTRACRANIAL HYPERTENSION (\"INTRAPATHIC INTRACRANINAL HYPERTENSION(IIH)\"), OSTEOARTHRITIS (\"DEGENERATIVE JOINT DISEASE (DJD)\") AND INTERVERTEBRAL DISC DEGENERATION (\"DEGENERATIVE DISC DISEASE(DDD)\"). THE PATIENT WAS TREATED WITH SURGERY (ESSURE REMOVAL SURGERY). ESSURE WAS REMOVED. AT THE TIME OF THE REPORT, THE FIBROMYALGIA, IDIOPATHIC INTRACRANIAL HYPERTENSION, OSTEOARTHRITIS AND INTERVERTEBRAL DISC DEGENERATION OUTCOME WAS UNKNOWN. THE REPORTER CONSIDERED FIBROMYALGIA, IDIOPATHIC INTRACRANIAL HYPERTENSION, INTERVERTEBRAL DISC DEGENERATION AND OSTEOARTHRITIS TO BE RELATED TO ESSURE. QUALITY-SAFETY EVALUATION OF PTC: UNABLE TO CONFIRM COMPLAINT. MOST RECENT FOLLOW-UP INFORMATION INCORPORATED ABOVE INCLUDES: ON 16-JUN-2020: QUALITY SAFETY EVALUATION OF PTC. BASED ON THE AVAILABLE INFORMATION, A REVIEW OF OUR COMPLAINT RECORDS AND OTHER RELEVANT DATA WILL BE CONDUCTED; ANY NEW AND REPORTABLE INFORMATION THAT BECOMES AVAILABLE FROM OUR INVESTIGATION WILL BE PROVIDED IN A SUPPLEMENTARY REPORT." } ], "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": "06/29/2020" } ] }