Rappel de Medtronic Concerto

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Medtronic Inc. Cardiac Rhythm Disease Managment.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
  • ID de l'événement
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
  • Date de mise en oeuvre de l'événement
  • Date de publication de l'événement
  • Statut de l'événement
  • Pays de l'événement
  • Date de fin de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
    cardiac resynchronization therapy - Product Code NIK
  • Cause
    A subset of active implanted concerto crt-d and virtuoso icd devices worldwide (estimated at 6,300) may not meet expected device longevity due to gradually increasing current drain caused by low voltage capacitor degradation. this issue may present in the affected devices as reaching the recommended replacement time (rrt) earlier than projected. this issue does not compromise device functionalit.
  • Action
    An "Important Medical Device Information" letter, dated September 2009 was hand delivered by Medtronic Representatives beginning 09/09/09. The letter describes the issue, identifies affected devices and provides recommendations for patients with devices in the affected subset.. A Patient letter was mailed to patients beginning 09/28/09. For additional information: Doctors are advised to contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636; Device tracking managers are advised to contact your Medtronic representative, or the Patient Registration Department at 1-800-328-2518 x41832; and Patients are advised to contact Medtronic Patient Services number at 800-551-5544 ext. 41835.


  • Modèle / numéro de série
    serial numbers: PVU600353S, PVU600444S, PVU600455S, PVU600466S, PVU600476S, PVU600478S, PVU600494S, PVU600497S, PVU600502S, PVU600505S, PVU600506S, PVU600507S, PVU600508S, PVU600512S, PVU600516S, PVU600518S, PVU600520S, PVU600522S, PVU600526S, PVU600529S, PVU600531S, PVU600534S, PVU600535S, PVU600536S, PVU600539S, PVU600543S, PVU600549S, PVU600558S, PVU600561S, PVU600568S, PVU600571S, PVU600573S, PVU600574S, PVU600582S, PVU600585S, PVU600595S, PVU600597S, PVU600598S, PVU600605S, PVU600607S, PVU600612S, PVU600617S, PVU600618S, PVU600619S, PVU600621S, PVU600622S, PVU600627S, PVU600631S, PVU600638S, PVU600640S, PVU600641S, PVU600646S, PVU600648S, PVU600652S, PVU600660S, PVU600664S, PVU600665S, PVU600675S, PVU600679S, PVU600680S, PVU600681S, PVU600682S, PVU600683S, PVU600685S, PVU600692S, PVU600694S, PVU600695S, PVU600698S, PVU600699S, PVU600703S, PVU600706S, PVU600708S, PVU600709S, PVU600711S, PVU600713S, PVU600718S, PVU600719S, PVU600721S, PVU600722S, PVU600723S, PVU600729S, PVU600767S, PVU600768S, PVU600781S, PVU600800S, PVU600806S, PVU600807S, PVU600808S, PVU600816S, PVU600819S, PVU600823S, PVU600825S, PVU600833S, PVU600834S, PVU600837S, PVU600840S, PVU600892S, PVU600898S, PVU600917S, PVU600949S, PVU600951S, PVU600957S, PVU600961S, PVU601001S, PVU601011S, PVU601012S, PVU601015S, PVU601020S, PVU601034S, PVU601035S, PVU601044S, PVU601052S, PVU601054S, PVU601058S, PVU601085S, PVU601108S, PVU601110S, PVU601115S, PVU601117S, PVU601120S, PVU601124S, PVU601133S, PVU601136S, PVU601140S, PVU601141S, PVU601142S, PVU601146S, PVU601147S, PVU601151S, PVU601153S, PVU601154S, PVU601159S, PVU601160S, PVU601162S, PVU601163S, PVU601164S, PVU601168S, PVU601170S, PVU601171S, PVU601177S, PVU601183S, PVU601190S, PVU601195S, PVU601197S, PVU601210S, PVU601211S, PVU601214S, PVU601219S, PVU601228S, PVU601231S, PVU601233S, PVU601234S, PVU601241S, PVU601243S, PVU601249S, PVU601256S, PVU601257S, PVU601258S, PVU601263S, PVU601269S, PVU601270S, PVU601274S, PVU601276S, PVU601282S, PVU601284S, PVU601285S, PVU601287S, PVU601289S, PVU601293S, PVU601301S, PVU601304S, PVU601314S, PVU601317S, PVU601320S, PVU601322S, PVU601325S, PVU601326S, PVU601329S, PVU601333S, PVU601341S, PVU601342S, PVU601343S, PVU601345S, PVU601350S, PVU601351S, PVU601354S, PVU601366S, PVU601368S, PVU601381S, PVU601398S, PVU601405S, PVU601410S, PVU601413S, PVU601430S, PVU601432S, PVU601433S, PVU601437S, PVU601456S, PVU601495S, PVU601499S, PVU601505S, PVU601519S, PVU601520S, PVU601521S, PVU601523S, PVU601524S, PVU601528S, PVU601532S, PVU601533S, PVU601548S, PVU601551S, PVU601555S, PVU601573S, PVU601577S, PVU601578S, PVU601581S, PVU601582S, PVU601585S, PVU601586S, PVU601592S, PVU601593S, PVU601604S, PVU601607S, PVU601611S, PVU601612S, PVU601614S, PVU601620S, PVU601623S, PVU601625S, PVU601635S, PVU601642S, PVU601651S, PVU601677S, PVU601686S, PVU601688S, PVU601694S, PVU601718S, PVU601719S, PVU601721S, PVU601723S, PVU601836S, PVU613075S, PVU613083S, PVU613107S, PVU613111S, PVU613112S, PVU613119S, PVU613123S, PVU613125S, PVU613127S, PVU613128S, PVU613129S, PVU613139S, PVU613141S, PVU613144S, PVU613151S, PVU613152S, PVU613153S, PVU613159S, PVU613170S, PVU613171S, PVU613177S, PVU613178S, PVU613187S, PVU613200S, PVU613206S, PVU613237S.
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    Worldwide distribution (except Idaho and Wyoming) including countries of Australia, Austria, Belgium, Canada, Czech Republic, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Kuwait, Netherlands, Norway, Portugal, Saudi Arabi, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Description du dispositif
    This device is not approved in the United States. || Medtronic Concerto, C174AWK. Dual Chamber implantable cardioverter defibrillator with cardiac resynchronization therapy, atrial and ventricular therapies. Medtronic, Inc., Minneapolis, MN 55432 USA.
  • Manufacturer


  • Adresse du fabricant
    Medtronic Inc. Cardiac Rhythm Disease Managment, 8200 Coral Sea St. N.E., Saint Paul MN 55112
  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “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