Events

Rappel de Device Recall Brio DBS System

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
    61554
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0894-2013
  • Date de mise en oeuvre de l'événement
    2012-03-28
  • Date de publication de l'événement
    2013-02-28
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-08-15
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=108418
  • 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, electrical, implanted, for parkinsonian tremor - Product Code MHY
  • Cause
    Unintended fluid ingress into the device header has been shown.
  • Action
    St. Jude Medical sent an Important Product Field Corrective Action Device Information letter dated March 28, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to check their inventory for any unused product, isolate the affected product for return to St. Jude Medical. Their local representatiave would collect the unused inventory. Any unused product would be replaced with product once inventory becomes available. For patients with implanted product and no degradation of therapy, it is recommended dthat the devices not be unnecesssarily explanted. For patient with implanted product who experience diminished or loss of therapy customers were advised to follow the steps provided in the letter. Customers were asked to forward the notification to any institution in the event one or more patients or products could be potentially affected by this action. Customers wsere asked to maintain a record of thenotice along with the recommendations to ensure the effectiveness of the communication. For questions regarding this recall call 972-309-2154.

Device

Device Recall Brio DBS System
  • Modèle / numéro de série
    Model number 6788. All lots manufactured prior to 03/16/2012 are being recalled.
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - 53 consignees out of the US.
  • Description du dispositif
    Advanced Neuromodulation Systems, Brio DBS System implantable neurostimulator, IPG or R-IPG, Model 6788 Implantable Pulse Generator.
  • 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