BEUDAMED
    FDA Recall Terminated

    Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators.

    Recall: Z-1172-2009 · Initiated November 3, 2008

    Recall

    Recall Number
    Z-1172-2009
    Event Number
    51135
    Firm
    Medtronic Inc. Cardiac Rhythm Managment
    FEI Number
    2182208
    Product Code
    LWS
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 3, 2008
    Posted
    April 8, 2009
    Terminated
    May 10, 2012
    Address
    8200 Coral Sea St. N.E., Mounds View, MN, 55112

    Description

    Medtronic RV Lead Integrity Alert , Cat. # SW012, 1.0 software in EnTrust(R) (D153ATG, D153VRC, D154ATG, D154VRC) and EnTrust(R) Escudo (D144DRG, D144VRC) defibrillators.

    Reason

    Medtronic has identified an issue related to installation or removal of the Lead Integrity Alert software in EnTrust(R) and EnTrust(R) Escudo" defibrillators. In those devices only, installation or removal of LIA will inadvertently turn off two audible patient alerts.

    Action

    Between November 24 and December 9, 2008 US CRDM are responsible to hand deliver the consignee letter, a Medtronic "Urgent Patient Management Information," dated November 2008, to impacted physicians to make them aware of the issue and continue to promote and install LIA (by using the new LIA tipcard). For any physician listed that a confirmation sheet was not received by end of day, December 9, 2008, the letter was mailed to the physician on Dec 10, 2008. The letter described the issue and the product involved. The letter also gave recommendations and informed consignees in regard to a future update to the LIA software for EnTrust devices.

    Distribution

    Worldwide Distribution -- USA including states of AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, DC, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MI, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY and 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, Netherlands, Netherlands Antilles, Norway, Oman, Peru, Poland, Portugal, Puerto Rico, Qatar, Reunion, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Turkey, United Arab Emirates, United Kingdom Vatican City State, Venezuela, and Virgin Islands.

    Quantity

    55,755