BEUDAMED
    FDA Recall Terminated

    Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.

    Recall: Z-1214-2010 · Initiated March 23, 2009

    Recall

    Recall Number
    Z-1214-2010
    Event Number
    54477
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 23, 2009
    Posted
    March 29, 2010
    Terminated
    July 10, 2012
    Address
    7000 Central Ave NE, Minneapolis, MN, 55432-3568

    Description

    Medtronic N'Vision 8870 Application Card for use in the Medtronic model 8840 Physician Programmer. Manufactured for: Medtronic, Inc., Minneapolis, MN 55432-5604 USA.

    Reason

    Routine monitoring of Medtronic's vigilance program identified user related programming errors. Medtronic has received reports of both overdose and underdose that were the result of programming use of SynchroMed implantable infusion pumps. These errors were most commonly associated with: --Priming Bolus Programming; and --Bridge Bolus Programming. Pump programming errors that result in overdos

    Action

    Medtronic is exchanging 8870 versions AAG, AAJ and BBG and replacing it with the updated versions AAH01 and BBH01. The updated versions contain user interface improvements to reduce the chance of user related programming errors when programming SynchroMed II and SynchroMed EL Infusion Pump system. A Medtronic "Medical Device Correction" letter was left behind for consignees. The letter was addressed to "Healthcare Provider" and was dated February 2009. The letter provided information regarding changes to the programming software used in SynchorMed Infusion System. For additional information, please contact your Medtronic Representative or Medtronic Neuromodulation Technical Services at 1-800-707-0933.

    Distribution

    All States in the US including DC. OUS: Austria Belgium Croatia Cyprus Czech Republic Denmark Estonia Faroe Islands Finland France French Polynesia Germany Greece Hungary India Ireland Israel Italy Kuwait Lebanon Malta Martinique Netherlands New Caledonia Norway Poland Portugal Reunion Russian Federation San Marino Saudi Arabia South Africa Spain Sweden Switzerland Turkey United Kingdom Vatican City State Canada Mexico Brasil

    Quantity

    8499 US