BEUDAMED
    FDA Recall Terminated

    Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.

    Recall: Z-0430-2012 · Initiated September 23, 2011

    Recall

    Recall Number
    Z-0430-2012
    Event Number
    60134
    Firm
    St Jude Medical CRMD
    FEI Number
    2017865
    Product Code
    DXY
    Status
    Terminated
    Root Cause
    Pending
    Initiated
    September 23, 2011
    Posted
    January 11, 2012
    Terminated
    April 10, 2012
    Address
    15900 Valley View Ct, Sylmar, CA, 91342-3577

    Description

    Anthem CRT-P models PM3110 and PM3210 St. Jude Medical pacemakers monitor and regulate a patient's heart rate with pacing therapy.

    Reason

    St. Jude Medical has received reports of out of range pacing lead impedance (PLI) measurements. These measurements are low and out of range (<200 ohms) but measure in range during visits to the clinic. The out of range readings are concluded as false.

    Action

    The firm, St. Jude Medical, sent an "IMPORTANT PRODUCT FIELD CORRECTION" letter dated September 22, 2011 to its customers by FedEx priority overnight service for planned receipt on September 23, 2011. The letter provides the customers with an explanation of the problem identified and an action to be taken. Customers were instructed that in order to prevent a false reading, a new programmer software version (12.1.0.1) is available. This software when used to interrogate an Accent DR or Anthem CRT-P pacemaker will eliminate the potential for this anomaly to occur. The onetime upgrade is performed automatically on affected devices and will not change the operation of the implanted device. A St. Jude Medical Sales Representative will assist the customers in loading the new programmer software onto their Merlin programmer. Customers with questions or concerns, can contact their local St. Jude Medical representative or their Technical services department at (800) 722-3774.

    Distribution

    Worldwide distribution: USA (nationwide) including Puerto Rico and countries of: Australia, Asia Pacific, Belgium, Bulgaria, Canada, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, India, Iran, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latin America, Lebanon, Malaysia, Netherlands, Norway, Oman, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, UK, and U.A.E.

    Quantity

    14,000 units