BEUDAMED
    FDA Recall Open, Classified

    MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x "My Therapy" Patient Therapy Application Software, Model Number A52300

    Recall: Z-0998-2022 · Initiated February 28, 2022

    Recall

    Recall Number
    Z-0998-2022
    Event Number
    89799
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    EZW
    Status
    Open, Classified
    Root Cause
    Software Design Change
    Initiated
    February 28, 2022
    Posted
    April 22, 2022
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    MEDTRONIC INTERSTIM THERAPY SYSTEM FOR URINARY CONTROL, which includes the following: a) Handset with Communicator, Model Numbers: 1) TH90Q01, 2) TH90QFA, 3) TH90PFA, 4) TH90GFA, 5) TG90G01; b) InterStim X Clinician Therapy Application Software, Model Number A51300; and c) InterStim x "My Therapy" Patient Therapy Application Software, Model Number A52300

    Reason

    There is a software anomaly with the InterStim X Clinician software application with results in the data entered in the Patient Information fields not e retained and a " Data Lost" notification being displayed.

    Action

    Medtronic distributed a correction notice to impacted U.S. implanting physicians, who had implanted patients with the Model 97800 InterStim X system prior to the release of the software update or purchased the TH90Q kit (in addition to notifying, Medtronic Sales Representatives and Medtronic Patient & Technical Services) on 28-Feb-2022. Medtronic distributed a correction notice to impacted U.S. hospital accounts, who have purchased the TH90Q kit containing the affected HH90 handset prior to the software updated release, on 04-Mar-2022, notifying consignees of this issue and the software update availability. Medtronic will also notify those consignees with the TH90PFA and TH90GFA kits where the affected software was installed.

    Distribution

    US Nationwide distribution in the states of FL, IL, WI, TX, CA, ND, NC, KY, AR, MO, MN, OH, CO, KS, MS, SC, LA, WA, PA, IN, SD, MI, WV, AL, GA, TN, VA, IA.

    Quantity

    1005 units