BEUDAMED
    FDA Recall Terminated

    Discovery II Multiprogrammable Pacemaker, DDD Model 981

    Recall: Z-0885-03 · Initiated May 6, 2003

    Recall

    Recall Number
    Z-0885-03
    Event Number
    26235
    Firm
    Guidant Corp-Cpi Division
    FEI Number
    2124215
    Product Code
    DXY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 6, 2003
    Posted
    May 29, 2003
    Terminated
    November 18, 2005
    Address
    4100 N Hamline Ave, St Paul, MN, 55112-5798

    Description

    Discovery II Multiprogrammable Pacemaker, DDD Model 981

    Reason

    In a rare circumstance (fallback mode when high-rate atrial activity is detected), the battery gauge can over-estimate battery life.

    Action

    An 'Important Pacemaker Follow-up Information' letter dated May 6, 2003 gave recommendations for avoiding the problem and indicated that updated software to prevent the problem would be introduced.

    Distribution

    Nationwide in the United States and worldwide.