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平成22年5月7日作成
一般名及び販売名
一般的名称 ： 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 販売名 ： コンサルタ ＣＲＴ‐Ｄ 一般的名称 ： デュアルチャンバ自動植込み型除細動器 販売名 ： セキュラ ＤＲ 一般的名称 ： 自動植込み型除細動器 販売名 ： セキュラ ＶＲ
対象ロット、数量及び出荷時期
対象型番 ： Ｄ２３４ＴＲＫ（コンサルタ ＣＲＴ‐Ｄ） ： Ｄ２３４ＤＲＧ（セキュラ ＤＲ） ： Ｄ２３４ＶＲＣ（セキュラ ＶＲ） 対象シリアル ：下記のとおり Ｄ２３４ＴＲＫ PYZ604478S PYZ604479S PYZ604480S PYZ604481S PYZ604483S PYZ604484S PYZ604729S PYZ604730S PYZ604732S PYZ604733S PYZ604735S PYZ604736S PYZ604737S PYZ604738S PYZ604739S PYZ604741S PYZ604742S PYZ604743S PYZ604744S PYZ604745S PYZ604747S PYZ604749S PYZ604750S PYZ604751S PYZ604752S PYZ604753S PYZ604755S PYZ604756S PYZ604762S PYZ604763S PYZ604764S PYZ604765S PYZ604766S PYZ604767S PYZ604769S PYZ604771S PYZ604772S PYZ604775S PYZ604776S PYZ604778S PYZ604779S PYZ604780S PYZ604782S PYZ604785S PYZ604790S PYZ604793S PYZ604794S PYZ604796S PYZ604797S PYZ604801S PYZ604802S PYZ604803S PYZ604877S PYZ604878S PYZ604880S PYZ604881S PYZ604882S PYZ604883S PYZ604884S PYZ604885S PYZ604886S PYZ604890S PYZ604891S PYZ604892S PYZ604893S PYZ604894S PYZ604898S PYZ604900S PYZ604901S PYZ604902S PYZ604904S PYZ604906S PYZ604907S PYZ604911S PYZ604913S PYZ604914S PYZ604916S PYZ604918S PYZ604920S PYZ604921S PYZ604922S PYZ604924S 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製造販売業者等名称
製造販売業者の名称 ： 日本メドトロニック株式会社 製造販売業者の所在地 ： 東京都港区東新橋二丁目１４番１号 コモディオ汐留 許可の種類 ： 第一種医療機器製造販売業 許可番号 ： １３Ｂ１Ｘ００２６１ 輸入先製造元 ： Ｍｅｄｔｒｏｎｉｃ ｉｎｃ．（米国）
回収理由
当該製品のソフトウェアに、極めて低い確率でエラーが起きる可能性があることが確認されました。 エラーは僅か数ミリ秒（ミリ秒とは１／１０００秒）の間に３つの事象が重なった場合にのみ発生し、この条件 が整うことは非常に稀であることが特定されております。 万一エラーが起きた場合、次回の充電時間が延長されます。この問題はプログラマを通じて製品のソフトウェア を修正することで解消されます。 弊社では、ソフトウェアの修正方法を医療機関にお知らせし自主的に改修することに致しました。
危惧される具体的な健康被害
万一エラーが起きた場合、次回の充電時間が延長され１回の充電でフル充電とならない場合があります。 その場合は、途中まで充電された状態から再度充電を行い高電圧治療の送出を試みます。３回連続でフル充電に ならない場合、 高電圧治療が送出されず、頻脈が持続する可能性があります。しかしながら、当該製品にはアラート機能（出荷 時ON設定）があり、 充電時間の延長時には警告音を発して患者様に医療機関の受診を促します。機器自体が定期的に行う自動キャパ シタフォーメーション（充電によるコンデンサ活性化機能）があり、 その際に充電時間の延長が認められた場合にも、警告音で患者様にお知らせします。また、遠隔モニタリング装 置（弊社製品名：ケアリンクモニタ）をご使用中の患者様の場合は、 警告音だけでなく、ケアリンクモニタを通じケアリンクウェブサイトの医療機関のアカウントに自動的に通知さ れます。 これらのアラート機能に加えて発生の可能性は稀なため、重篤な健康被害に至る恐れは極めて低いと考えられま す。 なお本事象に伴う健康被害は、国内外において報告されておりません。
回収開始年月日
平成２２年５月６日
効能・効果又は用途等
コンサルタ ＣＲＴ‐Ｄ ： 心拍を監視するために体内に植込み、頻拍が検出された場合には、心筋に除細動パルスを供給して心拍数を正常 まで低下させ、 徐脈が検出された場合には、ペースメーカパルスを供給して心拍数を正常まで上昇させる両室ペーシング機能付 き植込み型除細動器である。 セキュラ ＤＲ 及び セキュラ ＶＲ ： 心拍を監視するために体内に植込み、頻拍が検出された場合には、心筋に除細動パルスを供給して心拍数を正常 まで低下させ、 徐脈が検出された場合には、ペースメーカパルスを供給して心拍数を正常まで上昇させる植込み型除細動器であ る。
その他
対象機器の納入先及び対象となる患者様は、すべて弊社が把握しております。 弊社は全納入先に対し、今回の事象に関する情報とその対策に関する情報提供を行うとともに、ソフトウェアの 修正作業を実施致します。
担当者及び連絡先
担当者 ： 杉田 雄介 連絡先 ： 東京都港区東新橋二丁目１４番１号 コモディオ汐留 電話番号 ： ０３‐６４３０‐７０２５ ＦＡＸ番号 ： ０３‐６４３０‐７１１０