BEUDAMED
    FDA Recall Terminated

    Vitatron T-Series Dual Chamber pacemaker T60 DR, model T60A1. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventricular pacing. T-Series software VSF07/VSF08 Version 1.2. Vitatron is a division of Medtronic, Inc., Sales Office is Vitatron USA, 7000 Central Ave., NE, Minneapolis, MN 55423-3576. The head office is Vitatron B.V., P.O. Box 5227, 6802 EE Arnhem, The Netherlands

    Recall: Z-1000-2007 · Initiated February 5, 2007

    Recall

    Recall Number
    Z-1000-2007
    Event Number
    37587
    Firm
    Medtronic Inc. Cardiac Rhythm Managment
    FEI Number
    2182208
    Product Code
    NVZ
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    February 5, 2007
    Posted
    July 7, 2007
    Terminated
    October 16, 2008
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Vitatron T-Series Dual Chamber pacemaker T60 DR, model T60A1. The Vitatron C60 DR is a dual chamber rate responsive pacemaker (activity sensing using an accelerometer) for permanent atrial and ventricular pacing. T-Series software VSF07/VSF08 Version 1.2. Vitatron is a division of Medtronic, Inc., Sales Office is Vitatron USA, 7000 Central Ave., NE, Minneapolis, MN 55423-3576. The head office is Vitatron B.V., P.O. Box 5227, 6802 EE Arnhem, The Netherlands

    Reason

    Pacing rate: Software anomaly affecting Vitatron dual chamber C-series and T-series pacemakers, related to automatic retrograde conduction testing, can inhibit the device from pacing if the patient's intrinsic rate falls below the programmed lower rate.

    Action

    Advisory letters to physicians were mailed in February 2007. Sales respresentatives will follow-up with physicians by visit. A programmer software update will be released upon regulatory approval. The Advisory Letter provided short-term direction to reduce problems pending software upgrades.

    Distribution

    within the US to include: AL, AR, AZ, CA, CT, FL, GA, IL, IN, KY, MA, MD, MI, MN, NC, ND, NJ, NY, OH, OK, SC, TX.

    Quantity

    6,259