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Implantable Pulse Generator, Pacemaker (Non-Crt)（LWP）
植込み型心臓ペースメーカパルスジェネレータ（非CRT） この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。
113 件
直近 2026.05.06
0 件
2,376 件
157,474 件
分類情報
| Product Code | LWP |
|---|---|
| デバイス名 | Implantable Pulse Generator, Pacemaker (Non-Crt) 植込み型心臓ペースメーカパルスジェネレータ（非CRT） この日本語名は AI が生成した参考訳です。正式名称は英語の原名です。 |
| デバイスクラス | クラス III |
| 21 CFR 規制番号 | － |
| 審査区分 | PMA（市販前承認） |
| 医療専門分野 | Unknown |
| 定義 | These devices treat bradycardia (slow heartbeats) with RA and/or RV pacing therapy as necessary. これらの機器は、必要に応じてRAおよび/またはRVペーシング療法により徐脈（遅い心拍）を治療する。 この日本語訳は AI が生成した参考訳です。正確な内容は英語の原文をご確認ください。 |
| フラグ | インプラント機器 生命維持機器 |
| AI分析 | 本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）による審査を経て市場に出すことが求められています。クラスIIIは米国の医療機器規制の中で最も規制が厳しい区分であり、生命維持や健康に重大な影響を及ぼす可能性のある機器が対象とされ、510(k)による市販前届出ではなく、より詳細な科学的データの提出と審査が必要となるPMAが適用されます。 米国市場での動向 本製品コードでは、PMAとして本承認が約20件、一部変更承認が約2,400件承認されており、直近の判定は2026年7月となっています。不具合報告は累計で約15.5万件に達し、そのうち死亡報告は1,845件、傷害報告は約9万件と、不具合（Malfunction）よりも死亡・傷害の報告が多くを占めています。主な問題としては、Premature Discharge of Battery（電池の早期消耗）、Over-Sensing（過剰検知）、Incorrect, Inadequate or Imprecise Result or Readings（不正確・不十分な結果や読み取り）が挙げられています。回収は累計113件で、うちクラスI（最重篤）が29件、クラスIIが34件含まれており、直近5年では26件、最新の回収は2026年3月に開始されています。 この分析は公開データ（openFDA・JMDN 対応情報）をもとに AI が生成した参考情報です。市場データは2026年8月時点の集計に基づきます。 |
類似の国内医療機器（自動推定）
FDA デバイス分類と JMDN 英語名の名称・定義文の類似度から機械的に推定した候補です。日米の当局が定めた公的な対応関係ではなく、参考情報としてご覧ください。
| No. | 類別 | 一般的名称 | 品目数 | 企業数 | 年間総出荷額 | 成長率 | 平均価格 | 国産比率 |
|---|---|---|---|---|---|---|---|---|
| 1 | 内臓機能代用器 | 植込み型心臓ペースメーカクラスⅣ | 45 | 9 | 220.9 億円/年 | -2.6% | 43.27 万円/個 | 0.0% |
| 2 | 内臓機能代用器 | 植込み型両心室同期ペースメーカクラスⅣ | — | — | — | — | — | — |
| 3 | 内臓機能代用器 | 除細動機能なし植込み型両心室ペーシングパルスジェネレータクラスⅣ | 24 | 8 | 22.75 億円/年 | -20.5% | 128.76 万円/個 | 0.0% |
| 4 | 内臓機能代用器 | 除細動機能付植込み型両心室ペーシングパルスジェネレータクラスⅣ | 41 | 8 | 138.4 億円/年 | -25.9% | 190.72 万円/個 | 0.0% |
| 5 | 内臓機能代用器 | 植込み型ペースメーカアダプタクラスⅣ | 7 | 5 | 0.13 億円/年 | -2.6% | 672 円/個 | 0.0% |
FDA のデバイスクラスは 3 段階（クラス I〜III）、日本の医療機器は 4 段階（クラス I〜IV）で分類されており、 1 対 1 では対応しません。 リスク区分の考え方が異なるため、参考情報としてご利用ください。
米国での回収・承認・不具合報告
米国回収
全 113 件| 回収番号 | クラス | 回収開始日 | 企業 | 理由 | ステータス |
|---|---|---|---|---|---|
| Z-1770-2026 LWP | クラス I（最重篤） | 2026.03.19 | Boston Scientific Corporation | Updated software, Brady software maintenance release 6 (SMR6), is now available for the ACCOLADE" family of pacemakers and cardiac resynchronization therapy pacemakers (CRT-Ps)1 and the advisory population is expanding to include all CRT-P and dual-chamber extended life (DR-EL) devices. Dual chamber modes are specifically indicated for treatment of the following: " Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block " VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm " Low cardiac output or congestive heart failure secondary to bradycardia | 対応中 |
| Z-0100-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0099-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0098-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0097-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0096-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0095-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0094-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0092-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0091-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0090-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0089-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0088-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0087-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0086-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0085-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0084-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0083-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0082-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
| Z-0081-2026 LWP | クラス I（最重篤） | 2025.08.20 | Boston Scientific Corporation | Software to enhance Safety Architecture is available and designed to prevent initiation of Safety Mode in an ambulatory setting due to a high battery impedance state for the ACCOLADE family of devices which includes ACCOLADE, PROPONENT, ESSENTIO, and ALTRUA 2 dual chamber (DR) standard life (SL) and DR extended life (EL) pacemakers; and VISIONIST and VALITUDE cardiac resynchronization therapy pacemakers (CRT-Ps). | 対応中 |
510(k)（市販前届出）
この product code の 510(k) 情報はありません。
出典の openFDA は各 510(k) の主要（primary）product code のみを収録しているため、副次コードを含む FDA 公式データベースの検索結果とは件数が異なる場合があります。 FDA 510(k) データベースで確認
PMA（市販前承認）
全 2,376 件| PMA 番号 | 販売名 | 申請者 | 決定日 |
|---|---|---|---|
| P010015/S589 | Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar | Medtronic, Inc. | 2026.07.31 |
| P010015/S588 | Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T | Medtronic, Inc. | 2026.07.31 |
| P150012/S189 | ESSENTIO MRI SR SL (L110); ESSENTIO MRI DR SL (L111); ESSENTIO MRI DR EL (L131); PROPONENT MRI SR SL (L210); PROPONE | Boston Scientific | 2026.07.23 |
| N970003/S309 | ESSENTIO SR SL (L100); ESSENTIO DR SL (L101); ESSENTIO DR EL (L121); PROPONENT SR SL (L200); PROPONENT DR SL (L201) | Boston Scientific Corp | 2026.07.23 |
| P140033/S101 | Assurity MRI / Endurity MRI Pacemakers | ABBOTT MEDICAL | 2026.07.21 |
| P010015/S587 | Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P | Medtronic, Inc. | 2026.07.16 |
| P150012/S182 | INGENIO MRI, VITALIO MRI, FORMIO MRI, ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI | Boston Scientific | 2026.07.01 |
| N970003/S307 | ADVANTIO, INGENIO, VITALIO, FORMIO, ESSENTIO, ACCOLADE, PROPONENT, (INSIGNIA and ALTRUA 2 | Boston Scientific Corp | 2026.07.01 |
| P150012/S188 | LD INGEVITY PLUS AF | Boston Scientific | 2026.06.09 |
| P150012/S186 | Ingevity MRI Leads: Ingevity MRI Lead Models: 7731, 7732, 7735, 7736, 7740, 7741, 7742 Ingevity+ Lead Models: 7831, 7832 | Boston Scientific | 2026.06.03 |
| P150012/S185 | ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI | Boston Scientific | 2026.06.03 |
| N970003/S308 | ALTRUA 2, ESSENTIO, PROPONENT, ACCOLADE | Boston Scientific Corp | 2026.06.03 |
| P150012/S187 | INGEVITYTM+ Lead Passive Models | Boston Scientific | 2026.06.01 |
| P150012/S184 | INGEVITY MRI; INGEVITY+; INGEVITY+ Passive | Boston Scientific | 2026.05.19 |
| P150012/S183 | Stylet Models (5003, 5004, 5005, 5012, 5013, 5014); INGEVITY Attachable Suture Sleeve (aka Lead Stabilizer) (Model 6402 | Boston Scientific | 2026.05.15 |
| P010015/S583 | Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar | Medtronic, Inc. | 2026.05.14 |
| P010015/S581 | Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar | Medtronic, Inc. | 2026.04.30 |
| P140033/S102 | Assurity MRI, Endurity MRI family of Pacemakers | ABBOTT MEDICAL | 2026.04.24 |
| P010015/S585 | Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C | Medtronic, Inc. | 2026.04.23 |
| P010015/S586 | Attain Bipolar OTW Lead; Attain OTW L V Lead | Medtronic, Inc. | 2026.04.15 |
不具合報告（MAUDE）トレンド
米国不具合報告検索で詳しく見る出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
報告の存在は、機器と事象の因果関係を意味しません。報告件数を機器間の不具合発生率の比較に用いることはできません。
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。
出典: openFDA（U.S. FDA） のデータをそのまま掲載しています。内容の正確性・最新性は保証されません。FDA が本サイトの内容を承認・保証するものではありません。
取得日: 2026.09.28
各データセット（510(k)・PMA・MAUDE・回収・Warning Letter）の解説は 米国FDA情報の概要 を参照してください。