{ "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": "2026-07-07", "results": { "skip": 0, "limit": 1, "total": 256580 } }, "results": [ { "manufacturer_contact_zip_ext": "", "manufacturer_g1_address_2": "", "event_location": "I", "report_to_fda": "*", "manufacturer_contact_t_name": "", "manufacturer_contact_state": "", "manufacturer_link_flag": "Y", "manufacturer_contact_address_2": "", "manufacturer_g1_city": "", "manufacturer_contact_address_1": "", "manufacturer_contact_pcity": "", "event_type": "Injury", "report_number": "3004209178-2020-07713", "type_of_report": [ "Initial submission" ], "product_problem_flag": "N", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P860004", "date_of_event": "20200424", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "PHYSICIAN", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE", "HEALTH" ], "distributor_zip_code_ext": "", "manufacturer_g1_postal_code": "", "manufacturer_g1_state": "", "reporter_country_code": "US", "manufacturer_contact_area_code": "", "date_added": "20200427", "manufacturer_contact_f_name": "", "previous_use_code": "", "device": [ { "device_event_key": "", "implant_flag": "", "date_removed_flag": "", "device_sequence_number": "464032", "implant_date_year": "2019", "date_removed_year": "", "serviced_by_3rd_party_flag": "", "date_received": "20200427", "brand_name": "SYNCHROMED II", "generic_name": "PUMP, INFUSION, IMPLANTED, PROGRAMMABLE", "manufacturer_d_name": "MEDTRONIC PUERTO RICO OPERATIONS CO.", "manufacturer_d_address_1": "ROAD 31, KM. 24, HM 4", "manufacturer_d_address_2": "CEIBA NORTE INDUSTRIAL PARK", "manufacturer_d_city": "JUNCOS", "manufacturer_d_state": "PR", "manufacturer_d_zip_code": "00777", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "00777", "device_operator": "HEALTH PROFESSIONAL", "expiration_date_of_device": "20200728", "model_number": "8637-40", "catalog_number": "8637-40", "lot_number": "", "other_id_number": "", "device_availability": "No", "device_report_product_code": "LKK", "device_age_text": "", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00643169630512", "udi_public": "00643169630512", "openfda": { "registration_number": [ "3004209178" ], "fei_number": [ "3004369318" ], "device_name": "Pump, Infusion, Implanted, Programmable", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Adverse Event Without Identified Device or Use Problem", "Adverse Event Without Identified Device or Use Problem" ], "reporter_state_code": "FL", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "", "mfr_report_type": "Thirty-Day", "manufacturer_contact_country": "", "date_changed": "20250725", "health_professional": "", "summary_report_flag": "N", "manufacturer_g1_zip_code_ext": "", "manufacturer_contact_extension": "", "manufacturer_city": "", "manufacturer_contact_phone_number": "", "patient": [ { "patient_sequence_number": "1", "date_received": "20200427", "sequence_number_treatment": [ "" ], "sequence_number_outcome": [ "Required Intervention" ], "patient_age": "32 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "Erosion", "Skin Inflammation", "Erosion", "Skin Inflammation" ] } ], "distributor_city": "", "date_report": "20200427", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000424", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200424", "manufacturer_name": "", "report_source_code": "Manufacturer report", "remedial_action": [ "" ], "manufacturer_g1_zip_code": "", "report_to_manufacturer": "", "manufacturer_zip_code_ext": "", "manufacturer_g1_name": "", "adverse_event_flag": "Y", "distributor_address_1": "", "manufacturer_state": "", "distributor_address_2": "", "manufacturer_postal_code": "", "single_use_flag": "", "manufacturer_country": "", "mdr_text": [ { "mdr_text_key": "189005542", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "1", "text": "IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED." }, { "mdr_text_key": "189005703", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A COMPANY REPRESENTATIVE REGARDING A PATIENT RECEIVING BACLOFEN DOSE AND CON CENTRATION NOT REPORTED VIA AN IMPLANTABLE PUMP. ON (B)(6) 2020 A BLISTER AT THE POCKET SITE, POSSIBLE EROSION OR IT MAY BEGIN TO ERODE WAS REPORTED. THE ENVIRONMENTAL, EXTERNAL OR PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE WAS THE PATIENT WAS BEDRIDDEN. NO DIAGNOSTICS OR TROUBLESHOOTING WAS PERFORMED, AND THE ACTIONS AND INTERVENTIONS TAKEN TO RESOLVE THE ISSUE WAS THE PATIENT WAS SCHEDULED FOR POSSIBLE REVISION ON (B)(6) 2020. SURGICAL INTERVENTION DID NOT OCCUR BUT WAS PLANNED AND SCHEDULED FOR (B)(6) 2020. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. THE PATIENT STATUS WAS NOTED AS ALIVE, NO INJURY AND NO FURTHER COMPLICATIONS WERE REPORTED REGARDING THE EVENT." } ], "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": "" } ] }