2003年1月6日作成

1.　一般名及び販売名

一般的名称：植込み型心臓ペースメーカ
販　売　名：プロディジーＳＲ
承認番号　：20800BZY00995000

2.　対象ロット、数量及び出荷時期

モデル番号：8158
シリアル番号：
PEM100127H PEM110206H PEM110556H PEM400645H PEM401407H
PEM402000H PEM100135H PEM110208H PEM110557H PEM400672H
PEM401408H PEM402001H PEM100179H PEM110209H PEM110559H
PEM400673H PEM401409H PEM402002H PEM100180H PEM110210H
PEM110563H PEM400674H PEM401410H PEM402007H PEM100181H
PEM110211H PEM110568H PEM400675H PEM401461H PEM402008H
PEM100182H PEM110212H PEM110570H PEM400771H PEM401475H
PEM402010H PEM100183H PEM110213H PEM110571H PEM400791H
PEM401476H PEM402011H PEM100184H PEM110214H PEM110574H
PEM400793H PEM401477H PEM402012H PEM100185H PEM110215H
PEM110578H PEM400794H PEM401478H PEM402013H PEM100187H
PEM110216H PEM110583H PEM400795H PEM401487H PEM402026H
PEM100188H PEM110217H PEM110587H PEM400796H PEM401488H
PEM402047H PEM100189H PEM110218H PEM110588H PEM400797H
PEM401489H PEM402048H PEM100190H PEM110219H PEM110590H
PEM400798H PEM401490H PEM402095H PEM100191H PEM110220H
PEM110591H PEM400803H PEM401499H PEM402096H PEM100192H
PEM110221H PEM110594H PEM400804H PEM401500H PEM402097H
PEM100193H PEM110222H PEM110596H PEM400820H PEM401503H
PEM402098H PEM100194H PEM110224H PEM110598H PEM400825H
PEM401504H PEM402103H PEM100195H PEM110226H PEM110600H
PEM400891H PEM401505H PEM402104H PEM100196H PEM110227H
PEM110603H PEM400915H PEM401507H PEM402105H PEM100197H
PEM110228H PEM110606H PEM400961H PEM401508H PEM402106H
PEM100587H PEM110229H PEM110609H PEM400962H PEM401511H
PEM402115H PEM100588H PEM110230H PEM110610H PEM400963H
PEM401512H PEM402116H PEM100589H PEM110231H PEM110611H
PEM400964H PEM401513H PEM402117H PEM100590H PEM110232H
PEM110681H PEM400965H PEM401514H PEM402118H PEM100591H
PEM110233H PEM110698H PEM400966H PEM401595H PEM402119H
PEM100592H PEM110238H PEM200001K PEM400967H PEM401598H
PEM402120H PEM100593H PEM110356H PEM200002K PEM400968H
PEM401640H PEM402121H PEM100594H PEM110382H PEM200004K
PEM400969H PEM401648H PEM402122H PEM100595H PEM110383H
PEM200005K PEM400970H PEM401649H PEM402123H PEM100596H
PEM110384H PEM200006K PEM401179H PEM401650H PEM402124H
PEM100722H PEM110406H PEM400210H PEM401215H PEM401651H
PEM402125H PEM100740H PEM110442H PEM400211H PEM401216H
PEM401676H PEM402126H PEM100745H PEM110443H PEM400212H
PEM401217H PEM401677H PEM402273H PEM100756H PEM110447H
PEM400213H PEM401218H PEM401678H PEM402274H PEM100757H
PEM110448H PEM400215H PEM401227H PEM401679H PEM402275H
PEM100758H PEM110449H PEM400216H PEM401228H PEM401680H
PEM402277H PEM100759H PEM110541H PEM400217H PEM401229H
PEM401682H PEM402279H PEM100775H PEM110542H PEM400226H
PEM401230H PEM401684H PEM402280H PEM100820H PEM110543H
PEM400227H PEM401231H PEM401685H PEM402285H PEM100821H
PEM110544H PEM400228H PEM401232H PEM401696H PEM402286H
PEM100822H PEM110545H PEM400229H PEM401233H PEM401712H
PEM402287H PEM100823H PEM110546H PEM400230H PEM401399H
PEM401976H PEM402288H PEM110196H PEM110547H PEM400543H
PEM401400H PEM401977H PEM402289H PEM110197H PEM110548H
PEM400544H PEM401401H PEM401978H PEM402296H PEM110198H
PEM110549H PEM400572H PEM401402H PEM401979H PEM110199H
PEM110551H PEM400573H PEM401403H PEM401980H PEM110201H
PEM110553H PEM400629H PEM401404H PEM401981H PEM110203H
PEM110554H PEM400630H PEM401405H PEM401983H PEM110205H
PEM110555H PEM400631H PEM401406H PEM401999H

モデル番号：8160
シリアル番号：
PED405775H PED407008H PED408232H PED409097H PED409672H
PED409863H PED405777H PED407021H PED408233H PED409127H
PED409682H PED409864H PED405780H PED407022H PED408404H
PED409128H PED409683H PED409865H PED405781H PED407023H
PED408426H PED409129H PED409684H PED409866H PED405782H
PED407024H PED408438H PED409134H PED409685H PED409867H
PED405784H PED407026H PED408439H PED409135H PED409686H
PED409868H PED405786H PED407027H PED408440H PED409136H
PED409687H PED409869H PED405787H PED407028H PED408441H
PED409137H PED409689H PED409870H PED405789H PED407029H
PED408448H PED409139H PED409690H PED409871H PED405790H
PED407030H PED408475H PED409140H PED409691H PED409872H
PED405791H PED407031H PED408480H PED409141H PED409692H
PED409873H PED405793H PED407032H PED408493H PED409142H
PED409693H PED409874H PED405794H PED407033H PED408501H
PED409143H PED409695H PED409875H PED405795H PED407034H
PED408560H PED409144H PED409696H PED409876H PED405796H
PED407035H PED408577H PED409145H PED409697H PED409877H
PED405798H PED407036H PED408578H PED409146H PED409698H
PED409878H PED405799H PED407038H PED408579H PED409147H
PED409718H PED409879H PED405800H PED407039H PED408580H
PED409148H PED409719H PED409880H PED405801H PED407040H
PED408581H PED409154H PED409720H PED409881H PED405803H
PED407041H PED408582H PED409170H PED409723H PED409882H
PED406055H PED407045H PED408583H PED409172H PED409724H
PED409883H PED406089H PED407261H PED408584H PED409173H
PED409739H PED409884H PED406090H PED407854H PED408585H
PED409174H PED409745H PED409885H PED406091H PED407856H
PED408596H PED409360H PED409746H PED409886H PED406092H
PED407877H PED408597H PED409365H PED409751H PED409887H
PED406095H PED407878H PED408612H PED409371H PED409756H
PED409888H PED406096H PED407879H PED408613H PED409451H
PED409761H PED409889H PED406097H PED407880H PED408623H
PED409485H PED409766H PED409890H PED406098H PED407882H
PED408636H PED409528H PED409767H PED409891H PED406099H
PED407889H PED408637H PED409578H PED409768H PED409892H
PED406105H PED407894H PED408638H PED409579H PED409769H
PED409893H PED406106H PED407895H PED408640H PED409580H
PED409770H PED409894H PED406107H PED407896H PED408641H
PED409581H PED409771H PED409895H PED406108H PED407897H
PED408642H PED409582H PED409772H PED409896H PED406159H
PED407930H PED408643H PED409583H PED409773H PED409897H
PED406537H PED407931H PED408644H PED409584H PED409774H
PED409898H PED406538H PED407932H PED408645H PED409585H
PED409775H PED409899H PED406539H PED407933H PED408646H
PED409586H PED409776H PED409905H PED406540H PED407934H
PED408647H PED409587H PED409777H PED409906H PED406562H
PED407947H PED408661H PED409588H PED409778H PED409907H
PED406569H PED407948H PED408663H PED409589H PED409779H
PED409908H PED406572H PED407949H PED408664H PED409590H
PED409780H PED409909H PED406573H PED407982H PED408665H
PED409591H PED409781H PED409910H PED406574H PED407983H
PED408706H PED409592H PED409782H PED409911H PED406575H
PED407984H PED408707H PED409593H PED409783H PED409912H
PED406901H PED407985H PED408835H PED409594H PED409785H
PED409913H PED406908H PED408168H PED408848H PED409595H
PED409812H PED409914H PED406929H PED408185H PED408863H
PED409596H PED409813H PED409915H PED406930H PED408186H
PED408890H PED409597H PED409814H PED409916H PED406931H
PED408187H PED408923H PED409598H PED409815H PED409919H
PED406932H PED408188H PED408925H PED409599H PED409822H
PED409920H PED406933H PED408189H PED408926H PED409600H
PED409823H PED409921H PED406934H PED408192H PED408935H
PED409601H PED409824H PED409922H PED406937H PED408193H
PED408941H PED409602H PED409825H PED409923H PED406938H
PED408194H PED408945H PED409603H PED409826H PED409924H
PED406939H PED408195H PED408952H PED409604H PED409830H
PED409925H PED406940H PED408197H PED408955H PED409605H
PED409831H PED409926H PED406951H PED408198H PED408970H
PED409606H PED409833H PED409927H PED406971H PED408199H
PED408996H PED409607H PED409834H PED409928H PED406972H
PED408201H PED409027H PED409608H PED409836H PED409929H
PED406973H PED408203H PED409031H PED409609H PED409837H
PED409930H PED406974H PED408204H PED409074H PED409610H
PED409840H PED409931H PED406975H PED408205H PED409075H
PED409614H PED409841H PED409932H PED406976H PED408206H
PED409076H PED409615H PED409842H PED409933H PED406977H
PED408207H PED409077H PED409616H PED409843H PED409934H
PED406978H PED408208H PED409078H PED409617H PED409844H
PED409935H PED406979H PED408210H PED409079H PED409618H
PED409845H PED409936H PED406980H PED408211H PED409080H
PED409619H PED409846H PED409939H PED406985H PED408212H
PED409081H PED409620H PED409847H PED409940H PED406986H
PED408213H PED409082H PED409621H PED409848H PED409941H
PED406987H PED408215H PED409083H PED409622H PED409849H
PED409942H PED406988H PED408216H PED409084H PED409623H
PED409850H PED409943H PED406989H PED408217H PED409085H
PED409624H PED409851H PED409944H PED406990H PED408218H
PED409086H PED409625H PED409852H PED409945H PED406991H
PED408219H PED409087H PED409626H PED409853H PED409946H
PED406992H PED408222H PED409088H PED409627H PED409854H
PED409947H PED406994H PED408223H PED409089H PED409628H
PED409855H PED409948H PED406996H PED408224H PED409090H
PED409629H PED409856H PED409949H PED406997H PED408225H
PED409091H PED409630H PED409857H PED409950H PED406998H
PED408227H PED409092H PED409633H PED409858H PED406999H
PED408228H PED409093H PED409662H PED409859H PED407000H
PED408229H PED409094H PED409669H PED409860H PED407002H
PED408230H PED409095H PED409670H PED409861H PED407007H
PED408231H PED409096H PED409671H PED409862H

モデル番号：8161
シリアル番号：
PEE400928H PEE400957H PEE401208H PEE401323H PEE401333H
PEE401421H PEE400944H PEE401066H PEE401209H PEE401324H
PEE401334H PEE401424H PEE400950H PEE401067H PEE401280H
PEE401325H PEE401335H PEE401441H PEE400951H PEE401069H
PEE401289H PEE401326H PEE401336H PEE401488H PEE400952H
PEE401070H PEE401298H PEE401327H PEE401340H PEE401507H
PEE400953H PEE401071H PEE401317H PEE401328H PEE401341H
PEE401532H PEE400954H PEE401201H PEE401318H PEE401329H
PEE401348H PEE400955H PEE401202H PEE401320H PEE401330H
PEE401353H PEE400956H PEE401203H PEE401322H PEE401332H
PEE401381H

モデル番号：8162
シリアル番号：
PEF402615H PEF402691H PEF403244H PEF403595H PEF403673H
PEF404770H PEF402658H PEF402692H PEF403245H PEF403596H
PEF403674H PEF404775H PEF402663H PEF402693H PEF403246H
PEF403597H PEF403679H PEF404776H PEF402666H PEF402694H
PEF403247H PEF403618H PEF403680H PEF404781H PEF402668H
PEF402699H PEF403248H PEF403646H PEF403681H PEF404793H
PEF402670H PEF403232H PEF403249H PEF403664H PEF403682H
PEF404794H PEF402675H PEF403238H PEF403250H PEF403665H
PEF403683H PEF404796H PEF402676H PEF403239H PEF403251H
PEF403666H PEF403684H PEF404797H PEF402680H PEF403240H
PEF403252H PEF403669H PEF403685H PEF404799H PEF402681H
PEF403241H PEF403257H PEF403671H PEF404284H PEF402682H
PEF403242H PEF403258H PEF403672H PEF404431H

出荷数量：903
出荷時期：平成9年7月31日〜平成14年12月20日

3.　製造業者等名称

会社の名称：日本メドトロニック株式会社
本社所在地：神奈川県川崎市幸区堀川町580番地　ソリッドスクエア西館
営業所の所在地：東京都大田区平和島3-5-1　東京団地倉庫B棟
薬事の業態：医療用具輸入販売業
資本金：23億2千万円
従業員数：415名
許可番号：13BY6369
輸入先製造元：Medtronic Inc.（米国）

4.　回収理由

　社内における輸入承認申請書の自主点検にて、プログラマブルパラメータのパルス幅の一部の記載が欠落していることを確認しました。かかる承認書に記載されたパラメータと製品パラメータ間の不一致に鑑み、薬事法に則り、当該製品の改修の必要があると判断し自主改修に着手しました。

5.　危惧される具体的な健康被害

　本品の取扱説明書には正確な情報が記載されているため、本品の性能及び効能・効果、安全性に何ら影響を与えるものではありません。この記載漏れによる重篤な健康被害のおそれはまず考えられません。また、現在までにこの記載漏れに関連する不具合報告は受けておりません。

6.　回収開始年月日

平成14年12月27日（情報提供開始）

7.　効能・効果又は用途等

　本品は、心筋に長時間連続して電気刺激を与え、心臓のリズムを補正することを目的として使用する。

8.　その他

9.　担当者名及び連絡先

連絡先：日本メドトロニック株式会社
　　　　　神奈川県川崎市幸区堀川町580番地　ソリッドスクエア西館
電話　：044-540-6185
FAX　：044-540-6170
担当者：森村、松本、伊藤