Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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
    HPRA

6 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model Name: Product Model - Amplia MRI™ CRT-D SureScan™: ( DTMB2D1, DTMB1D4, DTMB2D4 ) - Amplia MRI™ Quad CRT-D SureScan™: ( DTMB2Q1, DTMB1QQ, DTMB2QQ) - Claria MRI™ CRT-D SureScan™: ( DTMA2D1, DTMA2D4) - Claria MRI™ Quad CRT-D SureScan™: (DTMA2Q1, DTMA2QQ )
  • Product Description
    Cardiac resynchronization therapy implantable defibrillator
  • Manufacturer
  • Model / Serial
  • Product Description
    Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™, Medtronic Inc
  • Manufacturer
  • Model / Serial
  • Product Description
    Medtronic: Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™
  • Manufacturer
One more