Device Recall Platinium DR 1510

  • Modèle / numéro de série
    All Serial Numbers
  • Classification du dispositif
  • Classe de dispositif
  • Dispositif implanté ?
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Platinium DR 1510, Model Number TDF032U, UDI/GTIN 08031527015521, Implantable cardioverter defibrillator, || Biventricular or ventricular antitachycardia pacing, || Dual or single chamber arrhythmia detection || Product Usage: || PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
  • Manufacturer
  • 1 Event


  • Adresse du fabricant
    Sorin Group Italia SRL - CRF, Via Crescentino, Saluggia, VC Italy
  • Société-mère du fabricant (2017)
  • Source