Events

Rappel de Device Recall Proclaim DRG Implantable Pulse Generator

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
    79560
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1170-2018
  • Date de mise en oeuvre de l'événement
    2018-03-09
  • Date de publication de l'événement
    2018-03-23
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=162647
  • 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 pulse generator, programmer and battery charger - Product Code PMP
  • Cause
    The firm received complaints of error messages that occurred during routine impedance checks on proclaim drg ipgs, model 3664. some complaints were also associated with transient over stimulation which created discomfort for the patients.
  • Action
    Notification material in the form of a Customer Letter was hand-delivered to two consignees in the US beginning 09 Mar 2018. The Physician Letter was hand-delivered to impacted implanting physicians, beginning 14 Mar 2018. A Patient Letter was delivered via certified mailing to all active implanted patients in the US, beginning 14 Mar 2018.

Device

Device Recall Proclaim DRG Implantable Pulse Generator
  • Modèle / numéro de série
    Lot Number 6210849 Serial Number AVM174.1  Lot Number 6210852 Serial Numbers: AVA560.1, AVA214.1, AVL027.1  Lot Number 6499208 Serial Numbers: AVD426.1, AVA922.1  Lot Number 6263128 Serial Numbers: AVB119.1, AVD400.1, AVA622.1, AVD431.1, AVE633.1,  AVK678.1, AVN837.1   Lot Number 6268723 Serial Numbers: AUV770.1, AVW805.1  Lot Number 6278155 Serial Number AVK896.1
  • Classification du dispositif
    Neurological Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US
  • Description du dispositif
    Proclaim DRG Implantable Pulse Generator, Model Number 3664
  • 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