BEUDAMED
    FDA Recall Open, Classified

    Model B35200 - Percept PC BrainSense Implantable Neurostimulator

    Recall: Z-0418-2022 · Initiated October 19, 2021

    Recall

    Recall Number
    Z-0418-2022
    Event Number
    88889
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    October 19, 2021
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Model B35200 - Percept PC BrainSense Implantable Neurostimulator

    Reason

    During cardioversion events, the Model B35200 Percept PC Implantable Neurostimulator could become unresponsive and non-functional. Cardioversion is a procedure performed by a cardiologist to correct an abnormal heartbeat. Medtronic has determined that the cardioversion may damage the circuit electronics in the Percept PC stimulator, thereby, causing the Percept PC stimulator to become non-responsive.

    Action

    Medtronic distributed a correction notice via mail courier service to impacted U.S. consignees, delivered 06-October-2021. A second attempt to notify US consignees is scheduled for the week of 08-November-2021. A third attempt to notify US consignees is scheduled for the week of 10-Jan-2022. In addition to Medtronic s communications to Percept PC implanting and managing physicians, Medtronic will notify affected patients implanted with Percept PC INS devices of this issue in the US. US Patient notifications are scheduled to happen within a month s timeframe. Medtronic will retain delivery confirmations for all patient notification mailings.

    Distribution

    Worldwide distribution - US Nationwide and Puerto Rico. The countries of Australia, Canada, Austria, Belgium, Canary Islands, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Israel, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, Slovakia, Slovenia, Spain, Sweden, Switzerland, United Kingdom, India, Japan, Korea, Republic Of, Argentina, Brazil, Colombia, Thailand, and Hong Kong.

    Quantity

    10,006 units