Events

Rappel de Device Recall Medtronic EnRhythm pacemaker

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
    54686
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1440-2010
  • Date de mise en oeuvre de l'événement
    2010-02-11
  • Date de publication de l'événement
    2010-04-26
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-01-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89015
  • 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 pacemaker pulse-generator - Product Code DXY
  • Cause
    Medtronic is informing doctors of two specific battery issues with enrhythm pacemakers that will be addressed by a medtronic software update available mid-2010. if the software update referenced above is not implemented, there will be a potential risk of loss of device functionality or risk for loss of therapy at or near eri in a small number of devices. the software will eliminate this issue, fo.
  • Action
    Consignees were given a Medtronic "Important : Medical Device Correction" letter addressed to "Dear Doctor" and dated February 2010. In the letter, Medtronic is informing doctors of two specific battery issues with EnRhythm pacemakers that will be addressed by a Medtronic software update available mid-2010. The letter included recommendations including that Medtronic recommends physicians continue to use the ERI notification to determine time for device replacement. At this time, no other action, reprogramming or change in the frequency of follow-up is recommended. For additional information or assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-505-4636.

Device

Device Recall Medtronic EnRhythm pacemaker
  • Modèle / numéro de série
    All EnRhythm pacemakers
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    All States in the USA including Guam, Puerto Rico and DC. OUS: Customers in the following countries: Andorra, Argentina, Aruba, Australia, Austria, Bangladesh, Belarus, Belgium, Brazil, Brunei, Darussalam, Canada, Cayman Islands, Chile, China, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Germany, Greece, Guam, Hong Kong, Hungary, India, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Kenya, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Malta, Mexico, Morocco, Netherlands, New Caledonia, New Zealand, Norway, Pakistan, Panama, Philippines, Poland, Portugal, Qatar, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Vatican City, Venezuela, Viet Nam, Virgin Islands
  • Description du dispositif
    Medtronic EnRhythm, P1501DR, Dual Chamber Rate Responsive Pacemaker with RapidRead Telemetry. The EnRhythm pacing system is an implantable medical device that monitors, detects, and treats atrial tachyarrhythmia episodes. It also provides bradycardia pacing and monitoring of ventricular tachycardia (VT) episodes. Manufactured at: Juncos, Puerto Rico, USA. Medtronic, Inc., Minneapolis, MN 55432 USA.
  • 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