Events

Rappel de Device Recall Eon Mini Neurostimulation Sysem

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 Advanced Neuromodulation Systems Inc..

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
    56787
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2607-2011
  • Date de mise en oeuvre de l'événement
    2011-05-24
  • Date de publication de l'événement
    2011-06-22
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-07-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94501
  • 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
    Defective battery was identified as cause for reports of inability to communicate or recharge the product.
  • Action
    St. Jude Medical sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers. St. Jude Medical recommends no action be taken if the product serial numbers do not match the numbers listed in the letter. For product remaining in unimplanted inventory, customers are instructed to contact their SJM representative so that product may be returned and replacements be provided. For implanted product that matches the serial numbers, the Medical Advisory Board recommend not to unnecessarily explant the devices if they are functioning as intended. Replacement devices will be provided at no additional cost to the customer. A Product Reconciliation Form was attached to the letter for customers to complete and return any unused product to the St. Jude Medical Neuromodulation Division at 6901 Preston Road., Plano, TX 75024. Questions regarding this recall are directed to the customer's St. Jude Medical Neuromodulation Division Representative.

Device

Device Recall Eon Mini Neurostimulation Sysem
  • Modèle / numéro de série
    Serial numbers 701029 through 13766511. Serial numbers containing supplier battery lot numbers 285 and below.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution-- USA (nationwide) including PUERTO RICO and countries of AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, FINLAND,FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, and UNITED KINGDOM.
  • Description du dispositif
    Eon Mini Neurostimulation (IPG) System Model 3788 || 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
    Advanced Neuromodulation Systems Inc.

Manufacturer

Advanced Neuromodulation Systems Inc.
  • Adresse du fabricant
    Advanced Neuromodulation Systems Inc., 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