BEUDAMED
    FDA Recall Terminated

    Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.

    Recall: Z-0612-2021 · Initiated November 19, 2020

    Recall

    Recall Number
    Z-0612-2021
    Event Number
    86907
    Firm
    Medtronic Neuromodulation
    FEI Number
    2182207
    Product Code
    MHY
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    November 19, 2020
    Terminated
    April 3, 2023
    Address
    7000 Central Ave Ne, Minneapolis, MN, 55432-3568

    Description

    Percept PC Implantable Neurostimulator (INS) - Product Usage: The Percept PC is a neurostimulation device for deep brain stimulation therapy. It is indicated for DBS treatment for Parkinson s disease, essential tremor, dystonia, obsessive-compulsive disorder, and epilepsy.

    Reason

    A software anomaly in the A620 Patient Programmer application was identified that results in failure to connect with the Percept PC device.

    Action

    Beginning November 19, 2020 accounts impacted by this issue were verbally notified to quarantine affected product. Beginning November 25, 2020 a recall notification letter and retrieval instructions titled "URGENT: MEDICAL DEVICE RECALL A620 Patient Programmer issue with specific Percept" PC Neurostimulators" was hand delivered to impacted accounts by Medtronic Representatives.

    Distribution

    US Nationwide distribution including in the states of Arizona, California, New Hampshire, Pennsylvania, Tennessee, Texas, Washington.

    Quantity

    12 devices