Dual Chamber Pacemaker

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DMA

6 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    Model: PM2112, Affected: Manufactured between Jul-2012 and Nov-2012
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Dual Chamber Pacemakers.Medtronic models: Kappa 600, 700, 800 and 900; EnPulse; Adapta; Versa; Sensia; Relia.Vitatron models: E50A1, E60A1 and G70A1.
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: ESPRIT DR (Lot serial: >10 NUMBERS CONTACT MFR); Model Catalog: REPLY 200 SR (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: REPLY 200 DR (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: REPLY SR (Lot serial: >1000 NUMBERS CONTACT MFR); Model Catalog: ESPRIT SR (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: REPLY DR (Lot serial: >1000 NUMBERS CONTACT MFR)
  • Description du dispositif
    ESPRIT DR PACEMAKER;REPLY 200 SR PACEMAKER;REPLY 200 DR PACEMAKER;REPLY SR PACEMAKER;ESPRIT SR PACEMAKER;REPLY DR PACEMAKER
  • Manufacturer
  • Modèle / numéro de série
    Model Catalog: 700 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 800 (Lot serial: ALL SERIAL NUMBERS); Model Catalog: 600 (Lot serial: ALL SERIAL NUMBERS)
  • Description du dispositif
    RUBY 700
  • Manufacturer
  • Modèle / numéro de série
    All lots/serial numbers
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    within the US to include: AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, NC, ND, NJ, NY, OH, OK, SC, TX.
  • Description du dispositif
    Vitatron T-Series Dual Chamber pacemaker T60 DR, model T60A1. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventricular pacing. T-Series software VSF07/VSF08 Version 1.2. Vitatron is a division of Medtronic, Inc., Sales Office is Vitatron USA, 7000 Central Ave., NE, Minneapolis, MN 55423-3576. The head office is Vitatron B.V., P.O. Box 5227, 6802 EE Arnhem, The Netherlands
  • Manufacturer
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