BEUDAMED
    FDA Recall Terminated

    Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153DRG and D154DRG. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment for automated treatment of life-threatening ventricular arrhythmias. Sterile. Medtronic, Inc., Minneapolis, MN 55432 USA.

    Recall: Z-1250-2012 · Initiated March 6, 2012

    Recall

    Recall Number
    Z-1250-2012
    Event Number
    61356
    Firm
    Medtronic Inc. Cardiac Rhythm Disease Management
    FEI Number
    2182208
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 6, 2012
    Posted
    March 22, 2012
    Terminated
    July 27, 2012
    Address
    8200 Coral Sea St. N.E., Saint Paul, MN, 55112

    Description

    Medtronic EnTrust, Dual Chamber Implantable, Cardioverter Defibrillator with Ventricular Therapies, models D153DRG and D154DRG. The implantable cardioverter defibrillator is intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment for automated treatment of life-threatening ventricular arrhythmias. Sterile. Medtronic, Inc., Minneapolis, MN 55432 USA.

    Reason

    A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage.

    Action

    An "Urgent Medical Device Correction" letter was sent to physicians beginning 3/6/2012. The letter described the issue and provided patient management recommendations. Additionally the letter stated that ongoing updates to the product performance report will be posted on a Medtronic website.

    Distribution

    Worldwide Distribution -- USA, and the countries of: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Bolivia, Brazil, Canada, Cayman Islands, Chile, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jamaica, Jordan, Kuwait, Lebanon, Macedonia, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Oman, Peru, Poland, Portugal, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela.

    Quantity

    68,804 devices worldwide