Viva ICD

  • Modèle / numéro de série
    Product Name: Viva XT CRT -D . Models: DTBA1D4, DTBA1D1. Serial Numbers:  BLF203128H, BLF204746H, BLE202888H, BLE202889H, BLE202890H, BLE202901H, BLE202941H, BLE202947H, BLE202954H, BLE202958H, BLE202961H, BLE202962H, BLE202964H, BLE202981H, BLE202987H, BLE202989H, BLE202990H, BLE202991H, BLE203019H, BLE203026H, BLE203027H, BLE203029H, BLE203032H, BLE203046H, BLE203052H, BLE203073H  Product Name: Viva S CRT-D. Models: DTBB1D4, DTBB1D1. Serial Numbers: BLO202272H, BLN202206H.
  • Classification du dispositif
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution - US Nationwide in the states of US: AZ, CA, FL, GA, IL, KY, MD, MN, NJ, NY, NC, OH, OK, PA, PR, TX. and countries of: Australia, Finland, France, Germany, Iran, Italy, Japan, Korea, Netherlands, Puerto Rico, Saudi Arabia, Spain, and United Kingdom.
  • Description du dispositif
    Medtronic, Viva Quadripolar Implantable Cardioverter Defibrillators: || Product Model || VIVAXTCRT-D DTBA1D1, DTBA1D4 || VIVASCRT-D DTBB1D1, DTBB1D4 || Product Usage: || The Medtronic Viva CRT -D dual chamber, implantable cardioverter defibrillator with cardiac resynchronization therapy (CRT -D) is a multiprogrammable cardiac device that monitors and regulates the patients heart rate by providing single or dual chamber, rate responsive bradycardia pacing; sequential biventricular pacing; ventricular tachyarrhythmia therapies; and atrial tachyarrhythmia therapies.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Medtronic Inc., Cardiac Rhythm and Heart Failure, 8200 Coral Sea St NE, Mounds View MN 55112-4391
  • 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
    USFDA