BEUDAMED
    FDA Recall Terminated

    Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.

    Recall: Z-0962-2017 · Initiated December 9, 2016

    Recall

    Recall Number
    Z-0962-2017
    Event Number
    75943
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure
    FEI Number
    2182208
    Product Code
    NIK
    Status
    Terminated
    Root Cause
    Software Design Change
    Initiated
    December 9, 2016
    Terminated
    July 16, 2019
    Address
    8200 Coral Sea St NE, Mounds View, MN, 55112-4391

    Description

    Amplia MRI" CRT -D SureScan", Amplia MRI" Quad CRT -D SureScan", Claria MRI" CRT -D SureScan", Claria MRI" Quad CRT -D SureScan. implantable medical devices that automatically detect and treat episodes of ventricular fibrillation, ventricular tachycardia, fast ventricular tachycardia, and bradyarrhythmia.

    Reason

    During internal testing conducted as part of next generation product development, it was discovered that the AdaptivCRT (aCRT) feature of Amplia MRI and Claria MRI CRT -D devices may appear to be enabled when it is not active.

    Action

    Consignees were hand delivered beginning on 12/9/2016 a Medtronic "Urgent Medical Device Correction" letter dated December 2016. The letter was addressed to "Dear Physician". The letter described the issue and the product involved in the recall. The letter informed consignees that a software update is being developed to address the issue and it will also address other issue not covered in this recall. The letter also included Appendix A which listed Patient Management Recommendations (Until the software update has been approved and the device models listed in Table A receive the update, follow the programming recommendations found in Appendix A. These recommendations also apply to any new device implants). Additionally, two other "Urgent Medical Device Correction" letters were hand delivered to the consignees, "Principal Investigator Contact Record" and a supplement to the advisory notification. For questions contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636.

    Distribution

    US: All states in USA including DC & PR. OUS: Australia, Finland, Japan, Saudi Arabia, Austria, France, Korea,Singapore, Bangladesh, Germany, Luxembourg, South Africa, Belgium, Greece, Malaysia, Spain, Brunei Darussalam, Guadeloupe, Netherlands, Sweden, Cayman Islands, Hong Kong, New Zealand, Switzerland, Chile, India, Norway, Thailand, Cyprus, Iran, Poland, Turkey, Denmark, Ireland, Portugal, United Arab Emirates, Dominican Republic, Italy, Reunion, United Kingdom.

    Quantity

    21,111 ( 13,198 US; 7,913 OUS).