Events

Rappel de Device Recall Eon Mini

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.

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
    63108
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1836-2013
  • Date de mise en oeuvre de l'événement
    2012-07-26
  • Date de publication de l'événement
    2013-07-31
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-08-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112563
  • 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
    Stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
  • Cause
    As part of st. jude medical's routine tracking and product monitoring, they have received a total of 214 reports, out of 34,617 eon mini ipgs, that lost the ability to communicate or recharge due to an inner battery weld issue resulting in loss of pain relief and subsequent explant. explant surgery, as with any surgery, presents a risk to patient health. adverse events associated with an unplanne.
  • Action
    St. Jude Medical sent a Important Medical Device Recall Advisory dated July 26, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. To further assist in your patient care we are providing you with a list of all serial numbers we show have been distributed to you. ( See Attachment A ). Further questions please call (972) 309-2154.

Device

Device Recall Eon Mini
  • Modèle / numéro de série
    Multiple lots recalled are the ones with supplier's inner battery lots of 326-508
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution--USA (nationwide) including Puerto Rico and the countries of Argentina, Australia, Austria, Belgium, Brazil, canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Ireland, Israel, Italy, Japan, Mexico, Netherlands, Saudi, South Africa, Spain, Sweden, Switzerland, Turkey and United Kingdom.
  • Description du dispositif
    Eon Mini - 3788 (IPG), || Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back, surgery syndrome, intractable low back and leg pain.
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • Adresse du fabricant
    St. Jude Medical, 6901 Preston Rd, Plano TX 75024-2508
  • 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