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
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US
  • Description du dispositif
    Proclaim DRG Implantable Pulse Generator, Model Number 3664
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    St. Jude Medical, Inc., 6901 Preston Rd, Plano TX 75024-2508
  • Société-mère du fabricant (2017)
  • 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