Events

Rappel de Medtronic Sprint Quattro Secure S, model 6947.

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
    57090
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0475-2011
  • Date de mise en oeuvre de l'événement
    2010-10-25
  • Date de publication de l'événement
    2010-11-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-02-04
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=95371
  • 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 (non-crt) - Product Code LWS
  • Cause
    Over-retraction of the helix during initial implant or subsequent repositioning may result in the inability to extend the helix. this does not impact acute or chronic performance of successfully implanted leads.
  • Action
    Medtronic issued an Important Medical Device Correction letter, dated October 2010, to doctors. The letter contains a Performance Note. The letter describes the issue and the performance note provides information on how to mitigate the issue through replacement with a new lead. Customers can contact Medtronic Technical Services at 800 723-4636

Device

Medtronic Sprint Quattro Secure S, model 6947.
  • Modèle / numéro de série
    all devices are affected, however, it is an issue that can present itself only at the time of the surgical procedure (acute issue) and it doesn't affect teh chronic performance of a successfully implanted lead.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: Throughout the US, including Guam, Puerto Rico, and US Virgin Islands, and to the countries of: Algeria, Argentina, Armenia, Australia, Austria, Bahamas, Bangladesh, Barbados, Belgium, Bolivia, Bosnia And Herzegovina, Brazil, Brunei Darussalam, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, El Salvador, Finland, France, Georgia, Germany, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kazakhstan, Kenya, Korea, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malaysia, Malta, Martinique, Mexico, Morocco, Netherlands, New Zealand, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Saint Lucia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad and Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Viet Nam.
  • Description du dispositif
    Medtronic Sprint Quattro Secure, model 6947. Steroid eluting, quadripolar, screw-in, ventricular lead with Right Ventricular (RV) and superior vena cava (SVC) defibrillation coil electrodes. Contents Sterile. Manufactured in: Villalba, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 U.S.A.
  • 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