Events

Rappel de Device Recall Medtronic Virtuoso

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 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
    52853
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1954-2009
  • Date de mise en oeuvre de l'événement
    2009-07-27
  • Date de publication de l'événement
    2009-08-18
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-05-31
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84134
  • 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
    Implantable cardioverter defibrillator (Single Chamber) - Product Code LWS
  • Cause
    Medtronic has detected a specific pattern of mosfet ic malfunctions in its concerto, virtuoso and enrhythm family of devices. the probability of occurrence decreases with time and, to date over 90% of the malfunctions related to the pattern have occurred within the first twelve months after implant.
  • Action
    Medtronic, Inc. personnel retrieved 2 non-implanted devices remaining at 2 hospitals. A Performance Notes letter was left at each facility. The Performance Notes described the issue, actions to address issue and recommendations to physicians. The Performance Notes will also be posted on the firm's website. Direct questions about this recall to Medtronic, Inc. by calling 1-763-514-4000.

Device

Device Recall Medtronic Virtuoso
  • Modèle / numéro de série
    Serial number: PUN421618H.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution-- (states of IA and NJ).
  • 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 Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • Adresse du fabricant
    Medtronic Inc. Cardiac Rhythm Managment, 8200 Coral Sea St. N.E., Mounds View 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