BEUDAMED
    FDA Recall Terminated

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

    Recall: Z-1193-2016 · Initiated January 26, 2016

    Recall

    Recall Number
    Z-1193-2016
    Event Number
    73150
    Firm
    QiG Group LLC
    FEI Number
    3010109865
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 26, 2016
    Posted
    March 18, 2016
    Terminated
    April 5, 2017
    Address
    10675 Naples St NE, Blaine, MN, 55449-5802

    Description

    Algostim LLC, Algovita Implanted Pulse Generator stimulator, Model 2412 ( 2 x 12 channel)

    Reason

    The implantable pulse generator (IPG) model 2408 had suboptimal performance establishing a connection to the external devices unless they were brought into close proximity (as close as 5 cm). The following functions may not be available: Reprogramming the stimulator, Adjusting stimulation parameters (on/off, intensity modifications, stimulation program selection), and Recharging the stimulator.

    Action

    Consignee was sent on 1/26/2016 a Algostim, LLC "Urgent Field safety Notice" dated January 21, 2016. The letter described the problem and the product involved in the recall. The letter provided Background information as well as described the Clinical Implications, Rate of Occurrence, Recommendations and Mitigations. Advised consignee to deliver the respective letter to each physician who have implanted affected product and collect signed Response forms.

    Distribution

    Distributed in Germany and Luxembourg.

    Quantity

    34