[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QPY":3},{"classification":4,"mappedDevices":40,"similarCandidates":41,"relatedClassifications":124,"syncDates":125,"translation":132,"marketSummary":139,"recalls":160,"k510s":162,"pmas":164},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":9,"medical_specialty_description":10,"review_panel":11,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":15,"gmp_exempt_flag":15,"raw":16,"created_at":34,"updated_at":35,"recall_count":36,"latest_recall_date":37,"k510_count":36,"pma_count":38,"event_count":39},5936,"QPY","Stimulator, Autonomic Nerve, Implanted For Stroke Rehabilitation","3","","Unknown","PM","2","Stimulation of the vagus nerve",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":9,"device_class":8,"implant_flag":31,"product_code":6,"review_panel":11,"gmp_exempt_flag":32,"third_party_flag":32,"medical_specialty":9,"regulation_number":9,"submission_type_id":12,"unclassified_reason":9,"life_sustain_support_flag":32,"medical_specialty_description":10,"summary_malfunction_reporting":33},{"fei_number":18,"pma_number":26,"registration_number":28},[19,20,21,22,23,24,25],"3013368220","3012309950","3014122529","3000206435","3010326622","3003574398","3030239420",[27],"P210007",[19,20,21,29,30,23,25],"2032521","2030624","Y","N","Ineligible","2026-08-18T05:52:52.949882+00:00","2026-08-24T02:00:47.513022+00:00",0,null,14,47,[],[42,51,59,67,76,84,92,100,108,116],{"medical_device_id":43,"generic_name":44,"class_classification":45,"jmdn_code":46,"name_similarity":47,"definition_similarity":48,"vector_similarity":49,"score":50},254,"植込み型迷走神経刺激電極及びリード","Ⅳ","44041000",0.294118,0.183673,0.74594,0.0317781,{"medical_device_id":52,"generic_name":53,"class_classification":45,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},321,"植込み型末梢神経無痛法用電気刺激装置","38474000",0.276596,0.0830565,0.697758,0.0295139,{"medical_device_id":60,"generic_name":61,"class_classification":45,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},299,"抗発作用迷走神経電気刺激装置","34210000",0.218391,0.126531,0.813337,0.0293805,{"medical_device_id":68,"generic_name":69,"class_classification":70,"jmdn_code":71,"name_similarity":72,"definition_similarity":73,"vector_similarity":74,"score":75},1623,"局所麻酔用神経刺激装置","Ⅱ","37042000",0.236842,0.0920502,0.727809,0.0290404,{"medical_device_id":77,"generic_name":78,"class_classification":45,"jmdn_code":79,"name_similarity":80,"definition_similarity":81,"vector_similarity":82,"score":83},6,"心臓・中枢神経刺激用プローブ","36957004",0.226667,0.161905,0.701079,0.0283702,{"medical_device_id":85,"generic_name":86,"class_classification":45,"jmdn_code":87,"name_similarity":88,"definition_similarity":89,"vector_similarity":90,"score":91},294,"昏睡覚醒用迷走神経電気刺激装置","37310000",0.204545,0.16568,0.803216,0.0279212,{"medical_device_id":93,"generic_name":94,"class_classification":45,"jmdn_code":95,"name_similarity":96,"definition_similarity":97,"vector_similarity":98,"score":99},305,"植込み型疼痛緩和用スティミュレータ","70600000",0.306667,0.0692042,0.664056,0.0276233,{"medical_device_id":101,"generic_name":102,"class_classification":45,"jmdn_code":103,"name_similarity":104,"definition_similarity":105,"vector_similarity":106,"score":107},320,"横隔神経電気刺激装置","35652000",0.230769,0.114035,0.699791,0.027598,{"medical_device_id":109,"generic_name":110,"class_classification":70,"jmdn_code":111,"name_similarity":112,"definition_similarity":113,"vector_similarity":114,"score":115},1469,"顔面神経刺激装置","35724000",0.272727,0.08,0.674675,0.0274972,{"medical_device_id":117,"generic_name":118,"class_classification":45,"jmdn_code":119,"name_similarity":120,"definition_similarity":121,"vector_similarity":122,"score":123},295,"精神療法用迷走神経電気刺激装置","37311000",0.191489,0.207143,0.805351,0.0274927,[],{"510k":126,"classification":127,"enforcement":128,"event":129,"pma":130,"warning_letter":131},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":133,"definition_ja":134,"commentary_ja":135,"model_name":136,"source_hash":137,"reviewed_by":37,"reviewed_at":37,"created_at":138,"updated_at":138},"脳卒中リハビリテーション用植込み型自律神経刺激装置","迷走神経の刺激である。","この機器は米国においてクラスIIIに分類されており、市販前承認（PMA）による審査を受ける必要があります。クラスIIIは人体へのリスクが高い、または有効性・安全性を裏付ける十分な情報がない機器に適用される区分であり、市販前届出（510(k)）よりも厳格な科学的根拠の提出が求められます。","claude-sonnet-5","6d3cf4dd0debb6bcaad1d0fc94123ab43651e36f91c46b6ac42b5d86b64bc76d","2026-08-24T03:31:52.244646+00:00",{"product_code":6,"summary_ja":140,"stats":141,"stats_hash":158,"model_name":136,"created_at":159,"updated_at":159},"本製品はPMA区分の機器で、本承認1件に加え一部変更承認が13件行われており、直近の判定は2026年6月となっています。不具合報告は累計で約50件寄せられており、その大半が傷害（約40件）で、不具合（Malfunction）としての報告は約4件、死亡報告は確認されていません。主な問題としてはHigh impedance、Failure to Interrogate、Lack of Effectが挙げられています。回収については累計0件であり、クラスI〜IIIいずれも報告は確認されていません。",{"pma":142,"k510":146,"as_of":147,"events":148,"recalls":152,"top_problems":154},{"latest":143,"originals":144,"supplements":145},"2026-06-18",1,13,{"total":36,"last5y":36,"latest":37,"applicants":36},"2026-08",{"death":36,"other":36,"total":39,"injury":149,"last5y":39,"malfunction":150,"latest_month":151},43,4,"2026-07",{"total":36,"last5y":36,"latest":37,"class_i":36,"class_ii":36,"class_iii":36,"top_root_causes":153},[],[155,156,157],"High impedance","Failure to Interrogate","Lack of Effect","dcdc29f901860fa787508f18a8a5e9be20c354735abc5a938aed015a92167c04","2026-08-24T05:19:21.416523+00:00",{"items":161,"total":36},[],{"items":163,"total":36},[],{"items":165,"total":38},[166,170,174,178,181,185,188,191,194,198,202,206,209,213],{"pma_number":27,"supplement_number":167,"trade_name":168,"applicant":169,"decision_date":143},"S014","Vivistim Pair VNS System","Mobia Medical, Inc.",{"pma_number":27,"supplement_number":171,"trade_name":172,"applicant":169,"decision_date":173},"S013","Vivistim® System","2026-04-10",{"pma_number":27,"supplement_number":175,"trade_name":176,"applicant":169,"decision_date":177},"S012","Vivistim® Paired VNS System","2026-04-01",{"pma_number":27,"supplement_number":179,"trade_name":172,"applicant":169,"decision_date":180},"S011","2026-03-02",{"pma_number":27,"supplement_number":182,"trade_name":183,"applicant":169,"decision_date":184},"S008","Vivistim® Paired VNS System","2026-02-26",{"pma_number":27,"supplement_number":186,"trade_name":172,"applicant":169,"decision_date":187},"S010","2026-01-28",{"pma_number":27,"supplement_number":189,"trade_name":172,"applicant":169,"decision_date":190},"S007","2025-09-03",{"pma_number":27,"supplement_number":192,"trade_name":172,"applicant":169,"decision_date":193},"S006","2025-05-30",{"pma_number":27,"supplement_number":195,"trade_name":196,"applicant":169,"decision_date":197},"S005","Vivistim System","2025-04-24",{"pma_number":27,"supplement_number":199,"trade_name":200,"applicant":169,"decision_date":201},"S004","MicroTransponder® Vivistim® Paired VNS System","2025-01-24",{"pma_number":27,"supplement_number":203,"trade_name":204,"applicant":169,"decision_date":205},"S003","MicroTransponder Vivistim Paired VNS System (Vivistim System)","2024-08-21",{"pma_number":27,"supplement_number":207,"trade_name":172,"applicant":169,"decision_date":208},"S002","2024-03-25",{"pma_number":27,"supplement_number":210,"trade_name":211,"applicant":169,"decision_date":212},"S001","MicroTransponder® Vivistim® Paired VNS System (Vivistim® System)","2022-02-16",{"pma_number":27,"supplement_number":9,"trade_name":172,"applicant":169,"decision_date":214},"2021-08-27"]