BEUDAMED
    FDA Recall Terminated

    MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    Recall: Z-2136-2019 · Initiated October 16, 2018

    Recall

    Recall Number
    Z-2136-2019
    Event Number
    81683
    Firm
    MED-EL Elektromedizinische Gereate, Gmbh Furstenweg 77a Innsbruck Austria
    FEI Number
    3000249315
    Product Code
    PGQ
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 16, 2018
    Terminated
    May 22, 2020

    Description

    MED EL Cochlear Implant System, Mi1000 MED EL CONCERTO, sold under the following implant types: a. Mil000 CONCERTO PIN +FLEX28; b. Mi1000 CONCERTO +FLEX28; c. Mi1000 CONCERTO PIN +FLEXsoft; d. Mil000 CONCERTO +Standard; e. Mil000 CONCERTO +Medium; f. Mi1000 CONCERTO PIN +Standard; g. M11000 CONCERTO +Compressed Product Usage: The Mi1000 CONCERTO Implant is an implantable part of the MED EL Cochlear Implant System and can only be used together with compatible MED EL external components. The MED EL Cochlear Implant System is intended to evoke auditory sensations via electrical stimulation of the auditory pathways for severely to profoundly hearing impaired individuals who obtain little or no benefit from acoustic amplification in the best aided condition.

    Reason

    Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

    Action

    Med-EL initially notified customers who had not yet implanted the affected devices on about 10/16/2018 via telephone call and followed up with an "Urgent-Medical Device Field Safety Notice (FSN)." The notice instructed customers to not implant the device if still available in inventory. Customers who had implanted the device were notified on about 11/27/2018 via telephone call and followed up with an "Urgent-Medical Device Field Safety Notice (FSN)." The notice instructed customers to immediately inform affected clinics of the recall and the long term risk. MED-EL does not recommend a device explantation, as the device may work as intended for years before the electronics may become affected by humidity ingress. Ultimately, accumulation of internal moisture may cause complete failure of the device. Should any uncomfortable or painful sensation be experienced, please stop immediately using the device and contact MED-EL or your local support center for immediate support. MED-EL recommends regular implant checks at least once a year to check the implant status. Additionally the customers were requested to respond to the FSN and confirm receipt.

    Distribution

    Worldwide distribution - US Nationwide in the states of California and Illinois. Countries of ARGENTINA, AUSTRALIA, AUSTRIA, BRAZIL, BULGARIA, CHINA, FRANCE, GEORGIA, KOREA, REPUBLIC OF, POLAND, RUSSIAN FEDERATION, SPAIN, SWEDEN.

    Quantity

    7 devices