BEUDAMED
    FDA Recall Open, Classified

    ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor

    Recall: Z-0421-2024 · Initiated November 3, 2023

    Recall

    Recall Number
    Z-0421-2024
    Event Number
    93411
    Firm
    Medtronic Inc.
    FEI Number
    2182208
    Product Code
    MXD
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    November 3, 2023
    Posted
    December 1, 2023
    Address
    8200 Coral Sea St Ne, Mounds View, MN, 55112-4391

    Description

    ICM LNQ22 LINQ II, Model LNQ22; Insertable Cardiac Monitor

    Reason

    It may create the potential for amplified noise and/or overall signal reduction of the ICM, which may interfere with intended recordings of heart rhythms. This noise pattern is different from occasional noise due to device position/migration, patient activity, or external electromagnetic interference.

    Action

    Medtronic issued a MEDICAL DEVICE PERFORMANCE NOTIFICATION to its consignees on 11/03/2023 via UPS 2-day delivery. The notice explained the issue, potential hazards, and requested the following actions: Encourage enrollment in and regular transmissions to CareLink. - Medtronic will apply recurring algorithmic searches on CareLink for the noise pattern and notify the clinician if present. The information used to identify this pattern is not visible to the clinician through CareLink. No further action is required for patients regularly transmitting to CareLink. For patients not followed in CareLink: - Consider whether enrolling in CareLink is an option, per HRS/EHRA/APHRS/LAHRS guidance.1 Ongoing CareLink monitoring will reduce the potential for episodes caused by amplified noise to overwrite true episodes before they are reviewed. - If noise interferes with the ability to assess the patient s rhythm or reason for monitoring, contact Medtronic Technical Services for assistance ([email protected] or 1-800-929-4043). On 06/19/2024, Medtronic sent an additional notice to consignees where they were notified of the additional units identified, encouraged enrollment in and regular transmissions to CareLink. For patients not followed with CareLink, consider enrolling. Hospitals were instructed to return unused units. Physicians were provided patient management recommendations. All consignees were requested to complete a confirmation form.

    Distribution

    US and Australia, Austria, Belgium, Brunei Darussalam, Canada, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Iceland, Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, Macao, Malaysia, Netherlands, New Zealand, Northern Ireland, Norway, Portugal, Puerto Rico, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, United Kingdom

    Quantity

    64,739 units