{ "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": 141894 } }, "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": "2124215-2020-09145", "type_of_report": [ "Initial submission", "Followup", "Followup" ], "product_problem_flag": "Y", "date_received": "20200427", "manufacturer_address_2": "", "pma_pmn_number": "P110042/S058", "date_of_event": "20200121", "reprocessed_and_reused_flag": "N", "manufacturer_address_1": "", "exemption_number": "", "manufacturer_contact_zip_code": "", "reporter_occupation_code": "003", "manufacturer_contact_plocal": "", "noe_summarized": "1", "manufacturer_contact_l_name": "", "source_type": [ "COMPANY REPRESENTATIVE" ], "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": "464461", "implant_date_year": "2019", "date_removed_year": "2020", "serviced_by_3rd_party_flag": "U", "date_received": "20200427", "brand_name": "EMBLEM MRI S-ICD", "generic_name": "IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)", "manufacturer_d_name": "BOSTON SCIENTIFIC CORPORATION", "manufacturer_d_address_1": "4100 HAMLINE AVENUE NORTH", "manufacturer_d_address_2": "", "manufacturer_d_city": "SAINT PAUL", "manufacturer_d_state": "MN", "manufacturer_d_zip_code": "55112", "manufacturer_d_zip_code_ext": "", "manufacturer_d_country": "US", "manufacturer_d_postal_code": "55112", "device_operator": "LAY USER/PATIENT", "expiration_date_of_device": "20210806", "model_number": "A219", "catalog_number": "A219", "lot_number": "251615", "other_id_number": "", "device_availability": "Device was returned to manufacturer", "date_returned_to_manufacturer": "20200511", "device_report_product_code": "LWS", "device_age_text": "DA", "device_evaluated_by_manufacturer": "", "combination_product_flag": "N", "udi_di": "00802526584404", "udi_public": "00802526584404", "openfda": { "registration_number": [ "2124215" ], "fei_number": [ "2124215" ], "device_name": "Implantable Cardioverter Defibrillator (Non-Crt)", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3" } } ], "product_problems": [ "Telemetry Discrepancy", "Interrogation Problem", "Telemetry Discrepancy", "Interrogation Problem" ], "reporter_state_code": "AK", "manufacturer_zip_code": "", "suppl_dates_mfr_received": "05/04/2020;05/24/2021", "mfr_report_type": "", "manufacturer_contact_country": "", "date_changed": "20250807", "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": [ "Hospitalization", " L", " R" ], "patient_age": "59 YR", "patient_sex": "", "patient_weight": "", "patient_ethnicity": "", "patient_race": "", "patient_problems": [ "No Known Impact Or Consequence To Patient", "No Clinical Signs, Symptoms or Conditions", "No Known Impact Or Consequence To Patient", "No Clinical Signs, Symptoms or Conditions" ] } ], "distributor_city": "", "date_report": "20210725", "initial_report_to_fda": "", "distributor_state": "", "event_key": "", "manufacturer_g1_country": "", "manufacturer_contact_city": "", "mdr_report_key": "10000644", "removal_correction_number": "", "number_devices_in_event": "", "date_manufacturer_received": "20200121", "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": "318695764", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS SUPPLEMENTAL REPORT IS BEING FILLED TO INCLUDE ADDITIONAL INFORMATION REGARDING THE FAILURE TO RESOLVE THE TELEMETRY ISSUE. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED." }, { "mdr_text_key": "318695765", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THIS SUPPLEMENTAL REPORT IS BEING FILLED TO INCLUDE ADDITIONAL INFORMATION REGARDING THE FAILURE TO RESOLVE THE TELEMETRY ISSUE. THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE EVENTS WERE REPORTED." }, { "mdr_text_key": "189011680", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "1", "text": "IT WAS REPORTED THIS PATIENT HAD DIFFICULTY WITH TELEMETRY WITH THEIR PROGRAMMER AT HOME. THE PATIENT WAS BROUGHT INTO THE CLINIC SHORTLY AFTER AND THERE WERE ADDITIONAL DIFFICULTIES INTERROGATING THE DEVICE WITH THE FIELD REPRESENTATIVES PROGRAMMER. TROUBLESHOOTING WAS PERFORMED WITHOUT SUCCESS. THE FIELD REPRESENTATIVE ADVISED THE PHYSICIAN TO CONTINUE WITH REMOTE MONITORING AND HAVE THE PATIENT FOLLOW-UP NORMALLY. THE SYSTEM IS STILL CURRENTLY IN SERVICE. NO ADVERSE EVENTS WERE REPORTED AT THIS TIME." }, { "mdr_text_key": "325712212", "text_type_code": "Description of Event or Problem", "patient_sequence_number": "0", "text": "THIS SUPPLEMENTAL REPORT IS BEING FILED DUE TO THE COMPLETED EVALUATION OF THIS PRODUCT." }, { "mdr_text_key": "325712213", "text_type_code": "Additional Manufacturer Narrative", "patient_sequence_number": "0", "text": "THIS DEVICE WAS THOROUGHLY INSPECTED AND ANALYZED UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY. VISUAL EXAMINATION IDENTIFIED NO ANOMALIES. DURING INITIAL TESTING, IT WAS NOTED THE BEHAVIOR OF THE DEVICE POINTED TO A POSSIBLE ISSUE WITH THE RADIO FREQUENCY (RF) HARDWARE STARTUP AND, AS SUCH, THE RF WAKE UP PERIODS WERE TESTED. INITIALLY, ALL WAKE UP PERIODS DURING THIS TESTING WERE CONSIDERED WITHIN THE ACCEPTABLE OPERATION THRESHOLD (I.E., THE RESULTS DID NOT FIND ANY CAPTURED PULSES THAT HAD A PULSE WIDTH OF LESS THAN 2MS); HOWEVER, THE MAXIMUM PULSE WIDTHS APPEARED TO BE DECREASING AS TEMPERATURES WERE INCREASED. THIS BEHAVIOR IS CONSISTENT WITH A SHORTENED TELEMETRY WAKE-UP PULSE BEHAVIOR ('RADIOFREQUENCY/RF WAKE-UP PERIOD') ASSOCIATED WITH THE CRYSTAL OSCILLATOR WITHIN THE RF CIRCUIT. ALTHOUGH THE S-ICD WAS ABLE TO BE SUCCESSFULLY INTERROGATED IN THE LABORATORY SETTING, THE VARYING AND INTERMITTENT TIMING DELAYS OBSERVED DURING TESTING LIKELY CAUSED OR CONTRIBUTED TO THE INABILITY TO ESTABLISH TELEMETRY WHILE IMPLANTED." } ], "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": "07/07/2020;07/25/2021" } ] }