Events

Rappel de Medtronic Sprint Fidelis Lead

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
    45403
  • Classe de risque de l'événement
    Class 1
  • Numéro de l'événement
    Z-0067-2008
  • Date de mise en oeuvre de l'événement
    2007-10-15
  • Date de publication de l'événement
    2007-10-25
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-06-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65383
  • 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 defibrillator lead - Product Code LWS
  • Cause
    Medtronic cardiac rhythm disease management has voluntarily suspended worldwide distribution of the sprint fidelis family of defibrillation leads because of the potential for lead fractures. in addition, the company recommends against new implants of the leads (sprint fidelis models: 6930, 6931, 6948, 6949). medtronic, its independent physician quality panel, and bruce lindsay, m.D., professor of.
  • Action
    A press release was issued by Medtronic on 10/15/2007. An FDA Statement was also issued on 10/15/2007. An Urgent Medical Device Information letter, dated 10/15/2007, was sent to physicians. The letter states that Medtronic has suspended distribution of the leads, the leads should no longer be implanted and unused leads should be returned to Medtronic. This letter describes background information, performance and recommendations. Medtronic believes it is inappropriate to prophylactically remove Sprint Fidelis leads except in unusual individual patient circumstances. An Important Patient Information letter was addressed to Medtronic Heart Device Patients. Both letters can be found on Medtronic's website at www.medtronic.com/fidelis. Return of product will be achieved with the assistance of Medtronic Representatives.

Device

Medtronic Sprint Fidelis Lead
  • Modèle / numéro de série
    all codes
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide, including USA, Puerto Rico, Guam, and Northern Mariana Islands.
  • Description du dispositif
    Medtronic Sprint Fidelis 6949 Steroid eluting, quadripolar, screw-in, ventricular lead with right ventricular (RV) / Superior Vena Cava (SVC) defibrillation coil electrodes. Sterile. This lead is designed for pacing, sensing, cardioversion and defibrillation therapies. Medtronic World Headquarters, Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • Adresse du fabricant
    Medtronic Inc. Cardiac Rhythm Managment, 7000 Central Ave Ne, Minneapolis MN 55432-3568
  • Source
    USFDA