BEUDAMED
    FDA Recall Terminated

    St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)

    Recall: Z-0298-2007 · Initiated October 6, 2006

    Recall

    Recall Number
    Z-0298-2007
    Event Number
    36619
    Firm
    St Jude Medical CRMD
    FEI Number
    2017865
    Product Code
    DXY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 6, 2006
    Posted
    December 19, 2006
    Terminated
    March 26, 2012
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    St. Jude Medical Identity SR Model 5172, Identity DR Model 5370, & Identity XL DR Model 5376; Pulse Generators (pacemakers)

    Reason

    St. Jude Medical has identified a low-frequency anomaly in the software used in the APS III Model 3500/3510 and Merlin PCS Model 3650 programmers that can lead to incorrect reporting of battery voltage, expected battery longevity and Elective Replacement Indicator (ERI) status.

    Action

    The notification material was sent to physicians by FedEx. The advisory notification was sent by FedEx on Oct. 12, 2006, to arrive at the physicians' offices on Oct. 13th. In the US, acknowledgement of receipt of the notification material will be monitored by St. Jude Medical CRMD in Sylmar, California. For the rest of the world it will be by various St. Jude offices and local distributors with this information being fed back to St. Jude Medical CRMD in Sylmar. In addition, St. Jude Medical issued a press release on October 13, 2006. Plus information concerning this advisory can be found on St. Jude's website, www.sim.com Completion of this advisory is estimated to be three months after its initiation.

    Distribution

    Worldwide in USA, ARGENTINA, AUSTRALIA, AUSTRIA, BARBADOS, BELGIUM, BERMUDA, BOLIVIA, BRAZIL, CANADA, CAYMAN ISLANDS, CHILE, CHINA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, ESTONIA, EUROPE, FINLAND, FRANCE, GERMANY, GREAT BRITAIN, GUATEMALA, HONG KONG, ICELAND, INDIA, ISRAEL, ITALY, JAPAN, JORDAN, SOUTH KOREA, LATVIA, LICHTENSTEIN, LUXEMBURG, MALAYSIA, MEXICO, NETHERLANDS, NEW CALEDONIA, NEW ZEALAND, NORWAY, PORTUGAL, SAUDI ARABIA, SLOVAKIA, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TUNISIA, UNITED KINGDOM & VENEZUELA

    Quantity

    199,065