Events

Rappel de Device Recall AdaptivCRT (aCRT)

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 and Heart Failure.

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
    75943
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0962-2017
  • Date de mise en oeuvre de l'événement
    2016-12-09
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=151797
  • 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
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
  • Cause
    During internal testing conducted as part of next generation product development, it was discovered that the adaptivcrt (acrt) feature of amplia mri and claria mri crt -d devices may appear to be enabled when it is not active.
  • Action
    Consignees were hand delivered beginning on 12/9/2016 a Medtronic "Urgent Medical Device Correction" letter dated December 2016. The letter was addressed to "Dear Physician". The letter described the issue and the product involved in the recall. The letter informed consignees that a software update is being developed to address the issue and it will also address other issue not covered in this recall. The letter also included Appendix A which listed Patient Management Recommendations (Until the software update has been approved and the device models listed in Table A receive the update, follow the programming recommendations found in Appendix A. These recommendations also apply to any new device implants). Additionally, two other "Urgent Medical Device Correction" letters were hand delivered to the consignees, "Principal Investigator Contact Record" and a supplement to the advisory notification. For questions contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

Device

Device Recall AdaptivCRT (aCRT)
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US: All states in USA including DC & PR. OUS: Australia, Finland, Japan, Saudi Arabia, Austria, France, Korea,Singapore, Bangladesh, Germany, Luxembourg, South Africa, Belgium, Greece, Malaysia, Spain, Brunei Darussalam, Guadeloupe, Netherlands, Sweden, Cayman Islands, Hong Kong, New Zealand, Switzerland, Chile, India, Norway, Thailand, Cyprus, Iran, Poland, Turkey, Denmark, Ireland, Portugal, United Arab Emirates, Dominican Republic, Italy, Reunion, United Kingdom.
  • Description du dispositif
    Amplia MRI" CRT -D SureScan", || Amplia MRI" Quad CRT -D SureScan", || Claria MRI" CRT -D SureScan", || Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.
  • Manufacturer
    Medtronic Inc., Cardiac Rhythm and Heart Failure

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure
  • Adresse du fabricant
    Medtronic Inc., Cardiac Rhythm and Heart Failure, 8200 Coral Sea St NE, Mounds View MN 55112-4391
  • 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