Events

Rappel de Medtronic Virtuoso VR

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
    Recall
  • ID de l'événement
    53294
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0129-2010
  • Date de mise en oeuvre de l'événement
    2009-09-09
  • Date de publication de l'événement
    2009-11-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-29
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85217
  • 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
    dual chamber ICDS - Product Code LWS
  • 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.

Device

Medtronic Virtuoso VR
  • Modèle / numéro de série
    serial numbers: PUN400013H, PUN400015H, PUN400016H, PUN400034H,  PUN400036H, PUN400039H, PUN402922H, PUN402926H, PUN415316H,  PUN416223H.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • 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
    Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Disease Managment

Manufacturer

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