BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 17070094 · Received June 6, 2023

    Report

    Report Number
    9710014-2023-00482
    Event Type
    Malfunction
    Date Received
    June 6, 2023
    Date of Event
    May 31, 2023
    Report Date
    October 5, 2023
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737062675
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: DAMAGE TO THE ACTIVE ELECTRODE, AS MIGHT BE CAUSED BY AN EXTERNAL MECHANICAL IMPACT, WAS DETERMINED TO BE THE ROOT CAUSE OF DEVICE FAILURE. THE ACTIVE ELECTRODE ALSO SHOWED SOME ADDITIONAL DAMAGE TO THE ELECTRODE WIRES, AS BEING CAUSED BY MINUTE DEVICE MOBILITY. AN ACCIDENT OR IMPACT MIGHT HAVE WEAKENED THE FIXATION OF THE IMPLANT, CONSEQUENTLY LEADING TO ELECTRODE MOBILITY. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    CORRECTION: ADDITION OF IMDRF INVESTIGATION FINDINGS RESULTS CODE: C070602.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ACCORDING TO THE CURRENTLY AVAILABLE INFORMATION, DAMAGE TO THE ACTIVE ELECTRODE AS MIGHT BE CAUSED BY THE REPORTED EXTERNAL MECHANICAL IMPACT APPEARS LIKELY. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE A DEVICE INVESTIGATION OF THE EXPLANTED DEVICE IS NECESSARY. THE RECIPIENT HAS BEEN RE-IMPLANTED, BUT THE CONCERNED DEVICE HAS NOT BEEN RECEIVED YET.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 0

    THE USER HAD MENINGITIS IN 2012. ON (B)(6) 2023, THE USER HAD A TRAUMA TO THE IMPLANT AREA AND AFTERWARDS HE WAS NO LONGER ABLE TO HEAR. THERE WERE NO VISIBLE SKIN DAMAGES. THE USER WAS RE-IMPLANTED.

    Description of Event or Problem · 0

    THE USER HAD MENINGITIS IN 2012. ON (B)(6) 2023, THE USER HAD A TRAUMA TO THE IMPLANT AREA AND AFTERWARDS HE WAS NO LONGER ABLE TO HEAR. THERE WERE NO VISIBLE SKIN DAMAGES. THE USER WAS RE-IMPLANTED.

    Description of Event or Problem · 0

    ON (B)(6), 2023, THE USER HAD A TRAUMA TO THE IMPLANT AREA AND AFTER IT HE CAN'T HEAR ANYMORE. THERE WERE NO VISIBLE SKIN DAMAGES. THE USER WAS REIMPLANTED ON (B)(6), 2023.

    Description of Event or Problem · 0

    ON (B)(6) 2023, THE USER HAD A TRAUMA TO THE IMPLANT AREA AND AFTER IT HE CAN'T HEAR ANYMORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570380 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT 09008737062675

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Unknown Required Intervention