BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2961219 · Received January 29, 2013

    Report

    Report Number
    9710014-2013-00028
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 28, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO 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 · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN CLINIC ON (B)(6) 2013, FOR PROGRAMMING DUE TO THE MOTHER'S CONCERN THAT THE CHILD IS NOT RESPONDING AS WELL TO SOUND AS PREVIOUSLY. HE IS A BILATERAL PATIENT, TESTING IN THE BOOTH PRIOR TO PROGRAMMING SHOWED GOOD RESPONSES IN THE BILATERAL CONDITION BUT NO RESPONSE FOR THE LEFT SIDE ALONE. NO RESPONSE WAS OBTAINED WITH THE BACK-UP PROCESSOR AS WELL. TROUBLESHOOTING REVEALED THE PROCESSORS TO BE FUNCTIONING APPROPRIATELY. NO REPORT OF HEAD TRAUMA AT OR AROUND THE IMPLANT SITE, NO CHANGE IN HEALTH STATUS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38465 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR