2003年1月6日作成

1.　一般名及び販売名

一般的名称：植込み型除細動器の導線
販　売　名：Sprint タンイド リード
承認番号　：20800BZY00628000

2.　対象ロット、数量及び出荷時期

モデル番号：6944-58
シリアル番号：
TDC004418V　TDC006056V　TDC007039V　TDC010147V　TDC014432V
TDC025334V　TDC004419V　TDC006057V　TDC007040V　TDC010148V
TDC014433V　TDC025335V　TDC004420V　TDC006058V　TDC007041V
TDC011347V　TDC014434V　TDC025336V　TDC004421V　TDC006059V
TDC007757V　TDC011348V　TDC014435V　TDC025337V　TDC004422V
TDC006060V　TDC007758V　TDC011349V　TDC014436V　TDC025338V
TDC004423V　TDC006061V　TDC007841V　TDC011350V　TDC014437V
TDC025339V　TDC004424V　TDC006062V　TDC007842V　TDC011401V
TDC014438V　TDC025340V　TDC004425V　TDC006063V　TDC009072V
TDC011402V　TDC014439V　TDC025341V　TDC004426V　TDC006200V
TDC009073V　TDC011403V　TDC014440V　TDC025342V　TDC004427V
TDC006408V　TDC009074V　TDC011404V　TDC014441V　TDC025343V
TDC004428V　TDC007004V　TDC009075V　TDC011405V　TDC014442V
TDC025344V　TDC004429V　TDC007005V　TDC009076V　TDC011406V
TDC014443V　TDC025345V　TDC004430V　TDC007006V　TDC009077V
TDC011729V　TDC014444V　TDC025347V　TDC004431V　TDC007007V
TDC009078V　TDC011730V　TDC017166V　TDC025348V　TDC004432V
TDC007008V　TDC009079V　TDC011732V　TDC017167V　TDC025349V
TDC004433V　TDC007009V　TDC009080V　TDC011733V　TDC017168V
TDC025350V　TDC004434V　TDC007010V　TDC009081V　TDC011734V
TDC017169V　TDC025351V　TDC004435V　TDC007011V　TDC009084V
TDC011735V　TDC017170V　TDC025352V　TDC004437V　TDC007012V
TDC009085V　TDC011736V　TDC017171V　TDC025353V　TDC004438V
TDC007013V　TDC009086V　TDC011737V　TDC022037V　TDC026086V
TDC004439V　TDC007014V　TDC009087V　TDC011738V　TDC022038V
TDC026087V　TDC004440V　TDC007015V　TDC009088V　TDC011740V
TDC022039V　TDC026088V　TDC004441V　TDC007016V　TDC009089V
TDC011741V　TDC022040V　TDC026089V　TDC004442V　TDC007017V
TDC009090V　TDC011742V　TDC022042V　TDC026091V　TDC004443V
TDC007018V　TDC009091V　TDC011795V　TDC022043V　TDC026092V
TDC006035V　TDC007019V　TDC009092V　TDC011796V　TDC022193V
TDC026093V　TDC006036V　TDC007020V　TDC009093V　TDC011797V
TDC022194V　TDC026094V　TDC006037V　TDC007021V　TDC009094V
TDC011798V　TDC022195V　TDC026095V　TDC006038V　TDC007022V
TDC009095V　TDC011799V　TDC022196V　TDC026096V　TDC006039V
TDC007023V　TDC009096V　TDC011800V　TDC022197V　TDC026097V
TDC006040V　TDC007024V　TDC009097V　TDC011801V　TDC022198V
TDC026098V　TDC006041V　TDC007025V　TDC009098V　TDC011802V
TDC022199V　TDC026099V　TDC006043V　TDC007026V　TDC009099V
TDC013108V　TDC022201V　TDC026100V　TDC006044V　TDC007027V
TDC009100V　TDC013110V　TDC022202V　TDC026101V　TDC006045V
TDC007028V　TDC009101V　TDC013111V　TDC022203V　TDC026102V
TDC006046V　TDC007029V　TDC009102V　TDC013113V　TDC025324V
TDC026103V　TDC006047V　TDC007030V　TDC009104V　TDC013114V
TDC025325V　TDC026104V　TDC006048V　TDC007031V　TDC009105V
TDC013115V　TDC025326V　TDC026546V　TDC006049V　TDC007032V
TDC009106V　TDC013870V　TDC025327V　TDC026547V　TDC006050V
TDC007033V　TDC009107V　TDC013871V　TDC025328V　TDC027117V
TDC006051V　TDC007034V　TDC009108V　TDC014427V　TDC025329V
TDC027118V　TDC006052V　TDC007035V　TDC009109V　TDC014428V
TDC025330V　TDC027119V　TDC006053V　TDC007036V　TDC009110V
TDC014429V　TDC025331V　TDC006054V　TDC007037V　TDC009111V
TDC014430V　TDC025332V　TDC006055V　TDC007038V　TDC010146V
TDC014431V　TDC025333V

モデル番号：6944-65
シリアル番号：
TDC004499V　TDC008629V　TDC013129V　TDC014412V　TDC019296V
TDC025230V　TDC004500V　TDC008630V　TDC013131V　TDC014413V
TDC019297V　TDC025231V　TDC004501V　TDC008631V　TDC013132V
TDC014414V　TDC019782V　TDC025232V　TDC004502V　TDC008632V
TDC013133V　TDC014415V　TDC019783V　TDC025233V　TDC004503V
TDC008633V　TDC013134V　TDC014416V　TDC019784V　TDC025234V
TDC004504V　TDC008634V　TDC013135V　TDC014417V　TDC019785V
TDC025235V　TDC004505V　TDC008635V　TDC013136V　TDC014418V
TDC019786V　TDC025236V　TDC004506V　TDC008636V　TDC013138V
TDC014419V　TDC019787V　TDC025237V　TDC004507V　TDC008637V
TDC013139V　TDC014420V　TDC019788V　TDC025238V

TDC004508V　TDC008638V　TDC013140V　TDC014421V　TDC019789V
TDC025239V　TDC004509V　TDC008639V　TDC013141V　TDC014422V
TDC019790V　TDC025240V　TDC004510V　TDC008640V　TDC013142V
TDC014423V　TDC019791V　TDC025241V　TDC004511V　TDC008641V
TDC013143V　TDC014424V　TDC019792V　TDC025242V　TDC004512V
TDC008642V　TDC013144V　TDC014425V　TDC019793V　TDC025243V
TDC004513V　TDC008643V　TDC013145V　TDC014426V　TDC019794V
TDC025244V　TDC005164V　TDC008644V　TDC013146V　TDC017354V
TDC019795V　TDC025245V　TDC005165V　TDC008645V　TDC013147V
TDC017355V　TDC019796V　TDC025246V　TDC005166V　TDC008646V
TDC013148V　TDC017356V　TDC019797V　TDC025247V　TDC005167V
TDC008647V　TDC013149V　TDC017357V　TDC019798V　TDC025248V
TDC005168V　TDC008648V　TDC013150V　TDC017358V　TDC019799V
TDC025249V　TDC005169V　TDC008649V　TDC013151V　TDC017359V
TDC019800V　TDC025379V　TDC005170V　TDC008650V　TDC013152V
TDC017360V　TDC019801V　TDC025380V　TDC005171V　TDC008651V
TDC013153V　TDC017361V　TDC019802V　TDC025383V　TDC005172V
TDC008652V　TDC013154V　TDC018134V　TDC019803V　TDC025385V
TDC005173V　TDC008653V　TDC013155V　TDC018135V　TDC019804V
TDC025386V　TDC006020V　TDC008654V　TDC013156V　TDC018136V
TDC019805V　TDC025387V　TDC006021V　TDC008655V　TDC013157V
TDC018137V　TDC019806V　TDC025388V　TDC006022V　TDC008656V
TDC013158V　TDC018138V　TDC019807V　TDC025389V　TDC006023V
TDC008657V　TDC013159V　TDC018139V　TDC019808V　TDC025390V
TDC006024V　TDC008658V　TDC013160V　TDC018140V　TDC019809V
TDC025391V　TDC006025V　TDC008659V　TDC013161V　TDC018141V
TDC019810V　TDC025392V　TDC006026V　TDC008660V　TDC013162V
TDC018142V　TDC019811V　TDC025393V　TDC006027V　TDC008661V
TDC013163V　TDC018143V　TDC019812V　TDC025394V　TDC006028V
TDC008662V　TDC013164V　TDC018144V　TDC019813V　TDC025395V
TDC006029V　TDC008663V　TDC013165V　TDC018145V　TDC019814V
TDC025396V　TDC006030V　TDC008664V　TDC013166V　TDC018146V
TDC019815V　TDC025397V　TDC006031V　TDC008665V　TDC013167V
TDC018149V　TDC019816V　TDC025398V　TDC006032V　TDC008666V
TDC013168V　TDC018150V　TDC019817V　TDC025399V　TDC006033V
TDC008667V　TDC013169V　TDC018151V　TDC019818V　TDC025400V
TDC006034V　TDC008668V　TDC013170V　TDC018152V　TDC019819V
TDC025401V　TDC006143V　TDC008669V　TDC013171V　TDC018153V
TDC019820V　TDC025402V　TDC006144V　TDC008670V　TDC013172V
TDC018154V　TDC019821V　TDC025403V　TDC006199V　TDC008671V
TDC013173V　TDC018156V　TDC020077V　TDC025404V　TDC006201V
TDC008672V　TDC013174V　TDC018157V　TDC020078V　TDC025405V
TDC006203V　TDC009163V　TDC013175V　TDC018158V　TDC020079V
TDC025459V　TDC006204V　TDC009164V　TDC013176V　TDC018159V
TDC020080V　TDC025460V　TDC006205V　TDC009165V　TDC013177V
TDC018160V　TDC020081V　TDC025461V　TDC006206V　TDC009166V
TDC013178V　TDC018161V　TDC021030V　TDC025462V　TDC006207V
TDC009167V　TDC013179V　TDC018162V　TDC021031V　TDC025463V
TDC006208V　TDC011513V　TDC013180V　TDC018163V　TDC021032V
TDC025464V　TDC006209V　TDC011514V　TDC013181V　TDC018164V
TDC021033V　TDC025465V　TDC006210V　TDC011515V　TDC013182V
TDC018165V　TDC021034V　TDC025466V　TDC006211V　TDC011516V
TDC013183V　TDC018166V　TDC021035V　TDC025467V　TDC006212V
TDC011517V　TDC013184V　TDC018167V　TDC021036V　TDC025468V
TDC006343V　TDC011518V　TDC013185V　TDC018168V　TDC021037V
TDC025469V　TDC006344V　TDC011519V　TDC014030V　TDC018169V
TDC021038V　TDC025470V　TDC006345V　TDC011520V　TDC014031V
TDC018170V　TDC021039V　TDC025471V　TDC006346V　TDC011521V
TDC014032V　TDC018171V　TDC021040V　TDC025472V　TDC006347V
TDC011522V　TDC014295V　TDC018172V　TDC021041V　TDC025473V
TDC006348V　TDC011523V　TDC014296V　TDC018174V　TDC021042V
TDC025474V　TDC006349V　TDC011524V　TDC014297V　TDC018176V
TDC021043V　TDC025475V　TDC006350V　TDC011525V　TDC014298V
TDC018177V　TDC021044V　TDC025476V　TDC006351V　TDC011526V
TDC014299V　TDC018178V　TDC021045V　TDC025477V　TDC006352V
TDC011527V　TDC014300V　TDC018283V　TDC021046V　TDC025478V
TDC006353V　TDC011528V　TDC014301V　TDC018284V　TDC021047V
TDC025479V　TDC006354V　TDC011529V　TDC014302V　TDC019017V
TDC021048V　TDC025480V　TDC006409V　TDC011530V　TDC014303V
TDC019018V　TDC021049V　TDC025481V　TDC006410V　TDC011532V
TDC014304V　TDC019019V　TDC021050V　TDC025482V　TDC006411V
TDC011533V　TDC014305V　TDC019020V　TDC021051V　TDC025483V
TDC006515V　TDC011534V　TDC014306V　TDC019021V　TDC021052V
TDC025484V　TDC006516V　TDC011535V　TDC014307V　TDC019022V
TDC021053V　TDC025750V　TDC006960V　TDC011536V　TDC014308V
TDC019024V　TDC021054V　TDC025751V　TDC006961V　TDC011537V
TDC014309V　TDC019025V　TDC021082V　TDC025752V　TDC006962V
TDC011538V　TDC014310V　TDC019026V　TDC021083V　TDC025753V
TDC006963V　TDC011539V　TDC014311V　TDC019027V　TDC021084V
TDC025754V　TDC006965V　TDC011540V　TDC014312V　TDC019028V
TDC021085V　TDC025755V　TDC006966V　TDC011803V　TDC014313V
TDC019029V　TDC021086V　TDC025756V　TDC006967V　TDC011804V
TDC014314V　TDC019030V　TDC021087V　TDC025757V　TDC006968V
TDC011805V　TDC014315V　TDC019031V　TDC021088V　TDC025758V
TDC006969V　TDC011806V　TDC014316V　TDC019032V　TDC021089V
TDC025759V　TDC006970V　TDC011807V　TDC014317V　TDC019033V
TDC021090V　TDC025760V　TDC006971V　TDC011808V　TDC014318V
TDC019034V　TDC021091V　TDC025761V　TDC006972V　TDC011809V
TDC014319V　TDC019035V　TDC021092V　TDC025762V　TDC006973V
TDC011810V　TDC014320V　TDC019036V　TDC021093V　TDC025763V
TDC006974V　TDC011811V　TDC014321V　TDC019037V　TDC021094V
TDC025764V　TDC006975V　TDC011812V　TDC014322V　TDC019038V
TDC021095V　TDC025765V　TDC006976V　TDC011813V　TDC014323V
TDC019039V　TDC021096V　TDC025766V　TDC006977V　TDC011814V
TDC014324V　TDC019040V　TDC021097V　TDC026190V　TDC006978V
TDC011815V　TDC014325V　TDC019041V　TDC021098V　TDC026191V
TDC006979V　TDC011816V　TDC014326V　TDC019042V　TDC021099V
TDC027120V　TDC006980V　TDC011817V　TDC014327V　TDC019043V
TDC021100V　TDC027121V　TDC006981V　TDC011818V　TDC014328V
TDC019044V　TDC021101V　TDC027122V　TDC006982V　TDC011819V
TDC014329V　TDC019045V　TDC021102V　TDC027124V　TDC006983V
TDC011820V　TDC014330V　TDC019046V　TDC021103V　TDC027125V
TDC006984V　TDC011821V　TDC014331V　TDC019047V　TDC021104V
TDC027126V　TDC006985V　TDC011822V　TDC014332V　TDC019269V
TDC021105V　TDC027127V　TDC006986V　TDC011823V　TDC014333V
TDC019270V　TDC024890V　TDC027128V　TDC006987V　TDC011824V
TDC014334V　TDC019271V　TDC024891V　TDC027129V　TDC006988V
TDC011825V　TDC014335V　TDC019272V　TDC024892V　TDC027131V
TDC006989V　TDC011826V　TDC014336V　TDC019273V　TDC024893V
TDC027132V　TDC006990V　TDC011827V　TDC014337V　TDC019274V
TDC024894V　TDC027133V　TDC006991V　TDC012252V　TDC014338V
TDC019275V　TDC024895V　TDC027134V　TDC006992V　TDC012253V
TDC014339V　TDC019276V　TDC024896V　TDC027136V　TDC006993V
TDC012254V　TDC014340V　TDC019278V　TDC024897V　TDC027137V
TDC006994V　TDC012255V　TDC014341V　TDC019279V　TDC024898V
TDC027138V　TDC006995V　TDC012256V　TDC014342V　TDC019280V
TDC024899V　TDC027139V　TDC006996V　TDC012257V　TDC014343V
TDC019281V　TDC024900V　TDC027140V　TDC006997V　TDC012258V
TDC014344V　TDC019282V　TDC024901V　TDC027142V　TDC006998V
TDC012259V　TDC014345V　TDC019283V　TDC024902V　TDC027143V
TDC006999V　TDC013116V　TDC014346V　TDC019284V　TDC024903V
TDC027145V　TDC007000V　TDC013117V　TDC014347V　TDC019285V
TDC024904V　TDC027146V　TDC007001V　TDC013118V　TDC014402V
TDC019286V　TDC024905V　TDC027150V　TDC007002V　TDC013119V
TDC014403V　TDC019287V　TDC024907V　TDC027153V　TDC007003V
TDC013120V　TDC014404V　TDC019288V　TDC024908V　TDC027155V
TDC008622V　TDC013122V　TDC014405V　TDC019289V　TDC024909V
TDC027156V　TDC008623V　TDC013123V　TDC014406V　TDC019290V
TDC024910V　TDC027159V　TDC008624V　TDC013124V　TDC014407V
TDC019291V　TDC024911V　TDC027161V　TDC008625V　TDC013125V
TDC014408V　TDC019292V　TDC024912V　TDC008626V　TDC013126V
TDC014409V　TDC019293V　TDC024913V　TDC008627V　TDC013127V
TDC014410V　TDC019294V　TDC024914V　TDC008628V　TDC013128V
TDC014411V　TDC019295V　TDC024915V

出荷数量：918　　　　　　　　　　　　　　　　
出荷時期：平成13年2月19日〜平成14年12月26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、チップ電極内の一部材料名に誤記載を確認しました。本品はステロイド溶出型リードで、ステロイドはチップ電極内に含まれています。このステロイドを固定するバインダー材料が「シリコーン樹脂」と記載すべきところを「ポリウレタン」と誤って記載されていました。かかる承認書に記載された材料名と製品材料名間の不一致に鑑み、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

　チップ電極に使用されている「シリコーン樹脂」は既承認品及び血液に接触する本品の他の部位に使用されている原材料と同じ材料です。従って、生物学的に安全であることが確認されている材料であるため、この誤記載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、現在までこの誤記載に起因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、心室性頻拍不整脈による突然死の危険性の高い症例に対して、植込み型除細動器（ＩＣＤ）とともに使用される。

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：渡辺、松本、伊藤