BEUDAMED
    FDA Recall Terminated

    Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient"s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient"s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient"s use of the system. The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs

    Recall: Z-1600-2016 · Initiated April 6, 2016

    Recall

    Recall Number
    Z-1600-2016
    Event Number
    73884
    Firm
    Nuvectra
    FEI Number
    3010309840
    Product Code
    LGW
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    April 6, 2016
    Posted
    May 3, 2016
    Terminated
    September 29, 2017
    Address
    10675 Naples St NE, Blaine, MN, 55449-5802

    Description

    Nuvectra, Algovita Spinal Cord Stimulation System Clinical Programmer, Model 4500. For use with Algovita Spinal Cord Stimulation Systems. The version of the software in the Clinician Programmer is v1.1.5. The Algovita Spinal Cord Stimulation system consists of a stimulator (EPG or IPG) that is physically and electrically connected to one or more leads inserted into the patient"s spinal epidural space. The lead delivers electrical stimulation originating at the stimulator with the purpose of blocking pain signals going to the patient"s brain. The stimulators are rechargeable, and the frequency of recharging is dependent on individual patient"s use of the system. The Clinician Programmer (CP) is a hand-held, touch screen device used to create and adjust stimulation parameters that are developed to optimize the therapy for each patient. The CP communicates with the stimulator via the Medical Implant Communication Service (MICS). The CP wirelessly transfers the stimulation parameters to the stimulator. In most clinical settings, the CP can be used by the Health Care Professional to program multiple patient EPGs and IPGs

    Reason

    If used, the optional Swap feature copies programming parameters from the external pulse generator (EPG) as well as unintended calibration data to the implantable pulse generator (lPG). This may result in the user being unable to recharge the lPG. This safety notice only applies to CPs Model 4500.

    Action

    Nuvectra sent an "Urgent Field Safety Notice" letter dated April 6, 2016 to customers. The letter identified the affected product, problem, recommendations and Mitigations, and actions to be taken.

    Distribution

    Germany

    Quantity

    17 OUS