BEUDAMED
    FDA Recall Terminated

    8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N''Vision Clinician Programmer.

    Recall: Z-1334-04 · Initiated August 24, 2004

    Recall

    Recall Number
    Z-1334-04
    Event Number
    29849
    Firm
    Medtronic Inc, Neurological & Spinal Division
    FEI Number
    2182207
    Product Code
    LKK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 24, 2004
    Posted
    September 23, 2004
    Terminated
    December 13, 2005
    Address
    800 53rd Ave Ne, Columbia Heights, MN, 55421-1241

    Description

    8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N''Vision Clinician Programmer.

    Reason

    With the Model 8870 software application card versions AAA 02, BBB 04, BBC 02, and BBD 01, which is used in conjunction with the Model 8840 N'Vision Clinician Programmer, users may have mistakenly entered a periodic bolus interval into the minutes field, rather than the hours field, resulting in drug overdoses. This issue is limited to programming the SynchroMed and SynchroMed EL pumps.

    Action

    Letters were distributed 8/24/2004 utilizing a courier with signed receipt upon delivery. The letters were signed for upon receipt at the consignee address, and the contents of the letter included a response form which can be faxed or mailed back to Medtronic. If any letters are returned as 'undeliverable', attempts will be made to telephone these consignees. A press release was issued on September 22, 2004 by Medtronic Inc. for all Version AAA 02 Model 8870 software application cards in the U.S.

    Distribution

    These cards were distributed primarily in the USA, but also to countries in Europe, Middle East and Africa, Canada, Australia, Hong Kong, Latin America and Japan.

    Quantity

    3,218 cards distributed in US, plus 1,248 distributed outside of the US