BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONCERTO

    MDR report key: 19368920 · Received May 22, 2024

    Report

    Report Number
    9710014-2024-00454
    Event Type
    Malfunction
    Date Received
    May 22, 2024
    Date of Event
    May 19, 2024
    Report Date
    January 30, 2025
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737306588
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: OVERLOAD FRACTURES IN THE ACTIVE ELECTRODE WHICH ARE CONSISTENT WITH AN EXTERNAL MECHANICAL IMPACT WERE 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. THE PROBLEMS GIVEN IN THE RECIPIENT REPORT APPEAR TO MATCH THE DAMAGE FOUND. THIS IS A FINAL REPORT.

    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ACCORDING TO THE CURRENTLY AVAILABLE INFORMATION, DAMAGE TO THE ACTIVE ELECTRODE LIKELY CAUSED BY MINUTE DEVICE MOBILITY IS SUSPECTED. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE A DEVICE INVESTIGATION OF THE EXPLANTED DEVICE IS NECESSARY. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.

    Description of Event or Problem · 0

    THE USER'S HEARING PERFORMANCE GRADUALLY WORSENED. THE PARENTS REPORTED THAT THE USER MIGHT HAVE HIT HER HEAD WHILE BATHING. THE USER HAS BEEN RE-IMPLANTED.

    Description of Event or Problem · 0

    THE USER'S HEARING PERFORMANCE GRADUALLY WORSENED. THE PARENTS REPORTED THAT THE USER MIGHT HAVE HIT HER HEAD WHILE BATHING. REIMPLANTATION IS BEING CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED YET.

    Description of Event or Problem · 0

    THE USER'S HEARING PERFORMANCE GRADUALLY WORSENED. THE PARENTS REPORTED THAT THE USER MIGHT HAVE HIT HER HEAD WHILE BATHING. REIMPLANTATION IS BEING CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1748954 CONCERTO COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT 09008737306588

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Female Required Intervention