Events

Rappel de Device Recall Percutaneous Trial Lead Kits

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, 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
    69025
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2719-2014
  • Date de mise en oeuvre de l'événement
    2014-07-29
  • Date de publication de l'événement
    2014-09-29
  • 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=129366
  • 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, implanted (pain relief) - Product Code GZB
  • Cause
    The directions for use (dfu) manual contains information for devices that are not approved in the us. the correct us approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
  • Action
    A field action was initiated with customer letters, dated July 29, 2014, and attached replacement DFUs. The letter identified the affected product and the reason for the recall. The recalling firm requested the consignees refer to the replacement DFU for guidance while using the device, and to discard the international manuals. Questions regarding the letter should be directed to customers' St. Jude Neuromodulation Representative or call the Technical Services Department at 1-800-727-7846.

Device

Device Recall Percutaneous Trial Lead Kits
  • Modèle / numéro de série
    Material 100077108, Batch 4519182
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of Texas and Illinois.
  • Description du dispositif
    Percutaneous Trial Lead Kit Model 3086 (8 ch percutaneous lead). || Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
  • Manufacturer
    St. Jude Medical, Inc.

Manufacturer

St. Jude Medical, Inc.
  • Adresse du fabricant
    St. Jude Medical, 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