BEUDAMED
    FDA Recall Terminated

    Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.

    Recall: Z-1537-06 · Initiated August 2, 2006

    Recall

    Recall Number
    Z-1537-06
    Event Number
    36164
    Firm
    Medtronic Neurological
    FEI Number
    2182207
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 2, 2006
    Posted
    September 29, 2006
    Terminated
    December 31, 2006
    Address
    800 53rd Ave NE PO Box 1250, Minneapolis, MN, 55440-1250

    Description

    Medtronic 3778 Lead Kit, 1x8 Compact Low Impedance Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at: Medtronic, Inc., Villalba, Puerto Rico USA. Medtronic, Inc., Minneapolis, MN 55432-5604.

    Reason

    Model 3777 Standard Octad Lead (Lot V009545) and Model 3778 Compact Octad Lead (Lot V009546) were mispackaged. The result of this error is that lead kits labeled 3777 lot V009545 may contain a 3778 compact-spaced lead, while those labeled 3778 lot V009546 may contain a 3777 standard-spaced lead. The result of this error is an overall increase or decrease of 14 mm in the electrode coverage.

    Action

    Medtronic representatives retrieved non-implanted devices. An Urgent Medical Device Recall letter was sent to physicians to describe the issue and patient management information.

    Distribution

    Nationwide distribution --- including states of CA, GA, KY, LA, and TX.

    Quantity

    22 total