BEUDAMED
    FDA Recall Open, Classified

    Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05

    Recall: Z-2512-2020 · Initiated June 4, 2020

    Recall

    Recall Number
    Z-2512-2020
    Event Number
    85816
    Firm
    Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)
    FEI Number
    2182208
    Product Code
    NVZ
    Status
    Open, Classified
    Root Cause
    Software design
    Initiated
    June 4, 2020
    Posted
    July 10, 2020
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    Serena CRT-P MRI, Model Numbers: a) W1TR02, b) W1TR05, c) W4TR02, d) W4TR05

    Reason

    There is a rare communication sequence during the first device interrogation with a SmartSync Device Manager that may result in the temporary suspension of some device features (i.e., battery measurements, Capture Management", Atrial Lead Position Check", EffectivCRT" algorithms, and AdaptivCRT"). This rare interaction results in temporary suspension of automatic threshold testing and output adjustments, and suspension of auto-optimization of CRT therapy. The issue is unlikely to result in clinical impact to the patient, and features are restored upon next programmer device interrogation or presence of a magnet.

    Action

    The firm initiated their medical device correction on 06/04/2020 by letter. The letter explained the problem and informed the consignee of the available software update (version 3.2.01) along with download instructions.

    Distribution

    worldwide

    Quantity

    17750 devices