Events

Retiro De Equipo (Recall) de Device Recall Secura VR

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Inc. Cardiac Rhythm Disease Managment.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    55922
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0116-2011
  • Fecha de inicio del evento
    2010-05-05
  • Fecha de publicación del evento
    2010-10-21
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2012-03-15
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92471
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Implantable cardioverter defibrillator (non-crt) - Product Code LWS
  • Causa
    Medtronic is informing you of a rare device software issue in certain icd and crt-d devices. a software update will be available to correct his issue. there have been 5 reports of this issue occurring with no reported patient injuries or deaths. medtronic has identified the root cause to be a rare and specific sequence of events that must occur within a few milliseconds of each other. in the u.
  • Acción
    Medtronic, Inc. sent an IMPORTANT MEDICAL DEVICE CORRECTION LETTER, dated May 2010 to physicians beginning May 05, 2010. The letter informed doctors of the issue and informed them that a software update would be available to correct this issue. The software was to be installed on the programmer, with a Medtronic representatives assistance, so that on a patient's next in-clinic interrogation the device would receive the upgrade automatically and their device would be corrected. For any questions regarding this recall physicians were to contact their local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Device

Device Recall Secura VR
  • Modelo / Serial
    Model D224VRC, serial numbers: PUX200008H thru PUX200046H, PUX200048H, PUX200049H, PUX200050H, PUX200051H, PUX200052H, PUX200053H, PUX200054H, PUX200055H, PUX200057H thru PUX200083H, PUX200085H thru PUX200141H, PUX200143H thruPUX200271H, PUX200273H thru PUX200369H, PUX200371H thru PUX200416H, PUX200418H thru PUX200465H, PUX200467H thru PUX200496H, PUX200498H thru PUX200577H, PUX200579H, PUX200581H, PUX200582H, PUX200583H, PUX200584H, PUX200585H, PUX200586H, PUX200587H, PUX200588H, PUX200589H, PUX200592H thru PUX200666H, PUX200668H thru PUX200731H, PUX200733H thru PUX200945H, PUX200947H thru PUX200962H, PUX200964H thru PUX201029H, PUX201031H thru PUX201054H, PUX201057H thru PUX201086H, PUX201088H thru PUX201101H, PUX201103H thru PUX201136H, PUX201139H, PUX201140H, PUX201141H, PUX201142H, PUX201144H, PUX201145H, PUX201150H, PUX201151H, PUX201152H, PUX201154H thru PUX201192H, PUX201194H thru PUX201344H, PUX201346H thru PUX201382H, PUX201384H thru PUX201626H, PUX201628H, PUX201630H, PUX201631H, PUX201632H, PUX201633H, PUX201634H, PUX201635H, PUX201636H, PUX201637H, PUX201638H, PUX201639H, PUX201640H, PUX201642H thru PUX201666H, PUX201668H, PUX201669H, PUX201670H, PUX201671H, PUX201672H, PUX201673H, PUX201674H, PUX201675H, PUX201676H, PUX201677H, PUX201678H, PUX201680H thru PUX201732H, PUX201734H, PUX201735H, PUX201736H, PUX201737H, PUX201739H, PUX201740H, PUX201742H thru PUX201823H, PUX201825H thru PUX201921H, PUX201923H thru PUX201946H, PUX201948H thru PUX201977H, PUX201979H thru PUX202194H, PUX202196H thru PUX202266H, PUX202268H thru PUX202368H, PUX202370H thru PUX202393H, PUX202395H, PUX202396H, PUX202399H thru PUX202516H, PUX202518H thru PUX202558H, PUX202560H, PUX202561H, PUX202562H, PUX202563H, PUX202564H, PUX202565H, PUX202566H, PUX202567H, PUX202568H, PUX202570H thru PUX202748H, PUX202750H thru PUX202852H, PUX202854H thru PUX202874H, PUX202876H thru PUX202917H, PUX202919H thru PUX203032H, PUX203034H thru PUX203117H, PUX203119H thru PUX203252H, PUX203254H thru PUX203303H, PUX203305H thru PUX203344H, PUX203346H, PUX203347H, PUX203348H, PUX203349H, PUX203350H, PUX203351H, PUX203353H thru PUX203414H, PUX203416H, PUX203417H, PUX203418H, PUX203419H, PUX203420H, PUX203423H, PUX203424H, PUX203425H, PUX203426H, PUX203427H, PUX203428H, PUX203429H, PUX203430H, PUX203431H, PUX203432H, PUX203433H, PUX203434H, PUX203436H, PUX203437H, PUX203438H, PUX203439H, PUX203441H, PUX203442H, PUX203443H, PUX203445H, PUX203446H, PUX203447H, PUX203448H, PUX203449H, PUX203450H, PUX203451H, PUX203452H, PUX203453H, PUX203455H thru PUX203528H, PUX203530H thru PUX203561H, PUX203563H thru PUX203584H, PUX203585H, PUX203586H, PUX203587H, PUX203590H thru PUX203663H, PUX203666H thru PUX203692H, PUX203694H thru PUX203838H, PUX203840H thru PUX203875H, PUX203877H thru PUX204186H, PUX204188H thru PUX204422H, PUX204424H thru PUX204658H, PUX204660H thru PUX204708H, PUX204710H, PUX204712H, PUX204713H, PUX204714H, PUX204715H, PUX204716H, PUX204717H, PUX204718H, PUX204719H, PUX204720H, PUX204721H, PUX204722H, PUX204723H, PUX204724H, PUX204725H, PUX204727H thru PUX204864H, PUX204866H thru PUX205008H, PUX205010H thru PUX205068H, PUX205070H thru PUX205256H, PUX205258H thru PUX205361H, PUX205363H thru PUX205397H, PUX205399H, PUX205400H, PUX205401H, PUX205402H, PUX205403H, PUX205404H, PUX205405H, PUX205406H, PUX205407H, PUX205408H, PUX205410H thru PUX205459H, PUX205461H thru PUX205629H, PUX205631H thru PUX205643H, PUX205645H thru PUX205670H, PUX205672H, PUX205673H, PUX205674H, PUX205675H, PUX205676H, PUX205677H, PUX205678H, PUX205679H, PUX205680H, PUX205681H, PUX205682H, PUX205683H, PUX205685H thru PUX205748H, PUX205750H thru PUX205767H, PUX205769H thru PUX206009H, PUX206011H thru PUX206044H, PUX206046H thru PUX206078H, PUX206080H thru PUX206128H, PUX206130H thru PUX206225H, PUX206227H thru PUX206382H, PUX206384H thru PUX206436H, PUX206438H thru PUX206480H, PUX206482H thru PUX206589H, PUX206591H thru PUX206669H, PUX206671H thru PUX206811H, PUX206813H thru PUX206911H, PUX206913H thru PUX206948H, PUX206951H thru PUX206991H, PUX206993H thru PUX207060H, PUX207062H thru PUX207300H, PUX207302H thru PUX207320H, PUX207322H thru PUX207343H, PUX207345H thru PUX207499H, PUX207501H thru PUX207584H, PUX207586H thru PUX207603H, PUX207605H thru PUX207643H, PUX207645H thru PUX207688H, PUX207690H thru PUX207830H, PUX207832Hthru PUX207877H, PUX207879H thru PUX207899H, PUX207901H thru PUX208119H, PUX208121H thru PUX208170H, PUX208172H thru PUX208285H, PUX208287H thru PUX208314H, PUX208316H thru PUX208372H, PUX208374H thru PUX208479H, PUX208481H, PUX208482H, PUX208483H, PUX208484H, PUX208485H, PUX208486H, PUX208487H, PUX208488H, PUX208489H, PUX208491H, PUX208492H thru PUX208560H, PUX208562H, PUX208563H, PUX208564H, PUX208565H, PUX208566H, PUX208567H, PUX208568H, PUX208569H, PUX208570H, PUX208571H, PUX208572H, PUX208573H, PUX208574H, PUX208576H, PUX208578H thru PUX208704H, PUX208706H thru PUX208728H, PUX208730H thru PUX208768H, PUX208770H thru PUX208784H, PUX208786H thru PUX208825H, PUX208827H, PUX208828H, PUX208829H, PUX208830H, PUX208832H thru PUX208891H, PUX208893H, PUX208894H, PUX208895H, PUX208896H, PUX208897H, PUX208898H, PUX208899H, PUX208900H, PUX208901H, PUX208902H, PUX208903H, PUX208905H, PUX208906H, PUX208907H, PUX208908H, PUX208909H, PUX208910H, PUX208911H, PUX208912H, PUX208913H, PUX208914H, PUX208916H thru PUX209024H, PUX209026H thru PUX209082H, PUX209084H thru PUX209147H, PUX209149H thru PUX209223H, PUX209225H thru PUX209283H, PUX209285H thru PUX209372H, PUX209374H thru PUX209441H, PUX209443H thru PUX209619H, PUX209621H thru PUX209702H, PUX209704H thru PUX209718H, PUX209720H, PUX209721H, PUX209722H, PUX209723H, PUX209724H, PUX209725H, PUX209727H thru PUX209752H, PUX209754H, PUX209755H, PUX209756H, PUX209757H, PUX209758H, PUX209759H, PUX209760H, PUX209762H thru PUX209882H, PUX209884H thru PUX209958H, PUX209960H thru PUX210135H, PUX210137H thru PUX210164H, PUX210166H thru PUX210183H, PUX210185H thru PUX210214H, PUX210216H thru PUX210272H, PUX210274H thru PUX210288H, PUX210290H thru PUX210318H, PUX210320H thru PUX210350H, PUX210352H, PUX210353H, PUX210354H, PUX210355H, PUX210356H, PUX210357H, PUX210358H, PUX210359H, PUX210360H, PUX210361H, PUX210362H, PUX210364H thru PUX210469H, PUX210471H thru PUX210509H thru PUX210632H, PUX210634H thru PUX210734H, PUX210736H thru PUX210847H, PUX210849H thru PUX210946H, PUX210948H thru PUX210975H, PUX210977H, PUX210978H, PUX210979H, PUX210981H thru PUX211093H, PUX211095H thru PUX211115H, PUX211117H thru PUX211303H, PUX211305H thru PUX211334H, PUX211336H thru PUX211399H, PUX211401H thru PUX211456H, PUX211458H thru PUX211574H, PUX211576H, PUX211577H, PUX211578H, PUX211579H, PUX211580H, PUX211582H thru PUX211603H, PUX211605H thru PUX211653H, PUX211655H thru PUX211704H, PUX211706H thru PUX211749H, PUX211751H, PUX211753H, PUX211754H, PUX211756H, PUX211758H, PUX211759H, PUX211760H, PUX211762H thru PUX211830H, PUX211832H thru PUX211846H, PUX211848H, PUX211855H, PUX211857H, PUX211859H, PUX211860H, PUX211862H, PUX211882H, PUX211884H thru PUX211902H, PUX211904H thru PUX211935H, PUX211937H thru PUX212287H, PUX212289H thru PUX212366H, PUX212368H, PUX212369H, PUX212370H, PUX212371H, PUX212372H, PUX212373H, PUX212374H, PUX212375H, PUX212376H, PUX212377H, PUX212379H thru PUX212399H, PUX212401H thru PUX212616H, PUX212618H thru PUX212628H, PUX212630H thru PUX212668H, PUX212670H thru PUX212727H, PUX212730H, PUX212731H, PUX212732H, PUX212733H, PUX212734H, PUX212735H, PUX212737H thru PUX212854H, PUX212856H thru PUX212914H, PUX600048S thru PUX600074S, PUX600076S thru PUX600106S.  Model D234VRC, serial numbers: PZF600099S thru PZF600114S, PZF600116S thru PZF600135S, PZF600333S thru PZF600350S, PZF600352S thru PZF600369S, PZF600371S thru PZF600409S, PZF600411S thru PZF600435S, PZF600437S, PZF600438S, PZF600439S, PZF600441S thru PZF600536S, PZF600539S, PZF600557S, PZF600558S, PZF600559S, PZF600561S thru PZF600601S, PZF600603S thru PZF600631S, PZF600634S, PZF600635S, PZF600636S, PZF600637S, PZF600638S, PZF600639S, PZF600640S, PZF600641S, PZF600642S, PZF600643S, PZF600644S, PZF600645S, PZF600647S thru PZF600668S, PZF600686S thru PZF600748S, PZF600750S thru PZF600825S, PZF600827S thru PZF600875S, PZF600881S thru PZF600917S, PZF600919S thru PZF601064S, PZF601066S thru PZF601092S, PZF601094S thru PZF601193S, PZF601195S thru PZF601358S, PZF601384S, PZF601385S, PZF601386S, PZF601387S, PZF601388S, PZF601389S, PZF601391S thru PZF601489S, PZF601491S thru PZF601627S, PZF601629S thru PZF601673S, PZF601675S, PZF601676S, PZF601677S, PZF601678S, PZF601679S, PZF601680S, PZF601681S, PZF601683S thru PZF601774S, PZF601776S thru PZF601845S, PZF601847S thru PZF601899S, PZF601901S, PZF601903S, PZF601904S, PZF601905S, PZF601906S, PZF601907S, PZF601908S, PZF601909S, PZF601910S, PZF601912Sthru PZF602056S, PZF602058S thru PZF602121S, PZF602123S thru PZF602154S, PZF602156S thru PZF602188S, PZF602190S thru PZF602206S, PZF602208S thru PZF602507S, PZF602509S thru PZF602531S, PZF602532S, PZF602533S, PZF602534S, PZF602535S, PZF602536S, PZF602537S, PZF602539S thru PZF602576S, PZF602578S thru PZF602638S, PZF602640S thru PZF602665S, PZF602667S thru PZF602734S, PZF602736S thru PZF602774S, PZF602776S thru PZF602875S, PZF602877S thru PZF603020S, PZF603022S thru PZF603122S, PZF603124S thru PZF603271S, PZF603273S thru PZF603329S, PZF603331S, PZF603332S, PZF603333S, PZF603334S, PZF603335S, PZF603336S, PZF603337S, PZF603338S, PZF603339S, PZF603340S, PZF603341S, PZF603342S, PZF603343S, PZF603344S, PZF603346S thru PZF603439S, PZF603441S thru PZF603477S, PZF603479S thru PZF603494S, PZF603496S thru PZF603576S, PZF603578S thru PZF603755S, PZF603757S thru PZF603940S, PZF603942S, PZF603943S, PZF603944S, PZF603945S, PZF603946S, PZF603947S, PZF603948S, PZF603950S thru PZF604161S, PZF604163S thru PZF604186S, PZF604188S, PZF604189S, PZF604190S, PZF604191S, PZF604192S, PZF604194S thru PZF604572S, PZF604574S thru PZF604841S, PZF604843S thru PZF604949S, PZF604951S thru PZF604975S, PZF604977S thru PZF605136S, PZF605138S thru PZF605169S, PZF605171S thru PZF605186S, PZF605188S thru PZF605227S, PZF605229S, PZF605230S, PZF605231S, PZF605232S, PZF605233S, PZF605234S, PZF605235S, PZF605236S, PZF605237S, PZF605238S, PZF605239S, PZF605240S, PZF605241S, PZF605242S, PZF605243S, PZF605245S thru PZF605279S, PZF605281S thru PZF605353S, PZF605355S thru PZF605370S, PZF605372S thru PZF605417S, PZF605419S thru PZF605753S, PZF605755S thru PZF605769S, PZF605771S thru PZF605785S, PZF605787S, PZF605788S, PZF605789S, PZF605790S, PZF605791S, PZF605792S, PZF605793S, PZF605795S thru PZF605844S, PZF605846S thru PZF605957S, PZF605959S thru PZF605982S, PZF605984S thru PZF606035S, PZF606037S thru PZF606135S, PZF606137S thru PZF606224S, PZF606226S thru PZF606273S, PZF606275S, PZF606276S, PZF606277S, PZF606278S, PZF606279S, PZF606280S, PZF606281S, PZF606283S thru PZF606409S, PZF606411S thru PZF606482S, PZF606484S thru PZF606530S, PZF606532S thru PZF606545S, PZF606547S thru PZF606588S, PZF606590S thru PZF606730S, PZF606732S thru PZF606759S, PZF606761S thru PZF606897S, PZF606899S thru PZF606915S, PZF606917S thru PZF606940S, PZF606942S, PZF606945S thru PZF606958S, PZF606960S thru PZF606970S, PZF606972S thru PZF607064S, PZF607066S thru PZF607142S, PZF607144S thru PZF607181S, PZF607183S, PZF607185S, PZF607186S, PZF607187S, PZF607188S, PZF607189S, PZF607190S, PZF607191S, PZF607192S, PZF607193S, PZF607194S, PZF607195S, PZF607196S, PZF607197S, PZF607198S, PZF607199S, PZF607200S, PZF607202S thru PZF607305S, PZF607307S, PZF607309S thru PZF607389S, PZF607391S thru PZF607401S, PZF607403S thru PZF607419S, PZF607421S thru PZF607441S, PZF607443Sthru PZF607515S, PZF607517S thru PZF607551S, PZF607553S thru PZF607612S, PZF607614S thru PZF607663S, PZF607665S thru PZF607697S, PZF607699S, PZF607700S, PZF607701S, PZF607702S, PZF607703S, PZF607704S, PZF607706S thru PZF607782S, PZF607784S thru PZF607998S, PZF608000S thru PZF608039S, PZF608041S thru PZF608095S, PZF608097S thru PZF608142S, PZF608144S, PZF608145S, PZF608146S, PZF608148S, PZF608149S, PZF608150S, PZF608152S thru PZF608187S, PZF608189S thru PZF608274S, PZF608276S thru PZF608284S, PZF608286S thru PZF608309S, PZF608311S, PZF608312S, PZF608313S, PZF608314S, PZF608316S thru PZF608443S, PZF608445S, PZF608446S, PZF608447S, PZF608448S, PZF608449S, PZF608450S, PZF608451S, PZF608452S, PZF608454S thru PZF608489S, PZF608491S thru PZF608603S, PZF608605S thru PZF608622S, PZF608624S thru PZF608641S, PZF608643S thru PZF608655S, PZF608657S thru PZF608680S, PZF608682S thru PZF608737S, PZF608739S, PZF608740S, PZF608958S, PZF608975S,
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution - USA, Puerto Rico, Virgin Islands, and the countries of Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Latvia, Lebanon, Libya, Luxembourg, Macedonia, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, and Viet Nam.
  • Descripción del producto
    Medtronic Secura VR, model D224VRC, and model D234VRC not available in the U.S.. Digital single chamber implantable cardioverter defibrillator (VVE-VVIR). Sterilized using ethylene oxide. Medtronic, Inc., Minneapolis, MN 55432 USA. Manufactured in: Juncos, Puerto Rico, USA. || The Dual chamber implantable cardioverter defibrillator (ICD) is a multiprogrammable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, ventricular tachyarrhythmia therapies, and atrial tachyarrhythmia therapies. The device automatically detects ventricular tachyarrhythmias (VT/VF) and provides treatment with defibrillation, cardioversion, and antitachycardia pacing therapies. The device also automatically detects atrial tachyarrhythmias (AT/AF) and provides treatment with cardioversion and antitachycardia pacing therapies. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Disease Managment
  • Dirección del fabricante
    Medtronic Inc. Cardiac Rhythm Disease Managment, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA