Events

Rappel de Device Recall Ellipse and Ellipse ST ICDs

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 St Jude Medical Cardiac Rhythm Management Division.

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
    69087
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2572-2014
  • Date de mise en oeuvre de l'événement
    2014-08-19
  • Date de publication de l'événement
    2014-09-03
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-10-08
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129605
  • 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
    An anomaly may result in delayed, partial, or no delivery of high voltage therapy. internal damage to the high voltage capacitors, which may result in extended charge time, occurring during capacitor maintenance or charging for high voltage therapy. it may present as a vibratory patient notification and upon interrogation, a programmer or merlin.Net alert.
  • Action
    A customer letter dated 8/19/14 was sent to physicians with the affected Ellipse ICDs on 8/20/14. The letter identifies the problems and the actions to be taken. Customers with any questions or concerns are instructed to contact their local St. Jude Medical representative or St. Jude Medicals Technical Services Department.

Device

Device Recall Ellipse and Ellipse ST ICDs
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution: US (nationwide), Canada, Australia, New Zealand, Japan, EU, Middle East, Latin America, and Asia-Pacific.
  • Description du dispositif
    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 || Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.
  • Manufacturer
    St Jude Medical Cardiac Rhythm Management Division

Manufacturer

St Jude Medical Cardiac Rhythm Management Division
  • Adresse du fabricant
    St Jude Medical Cardiac Rhythm Management Division, 15900 Valley View Ct, Sylmar CA 91342-3577
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA