BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2721348 · Received August 27, 2012

    Report

    Report Number
    9710014-2012-00309
    Event Type
    Malfunction
    Date Received
    August 27, 2012
    Report Date
    August 23, 2012
    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 PT WAS IMPLANTED IN THE RIGHT EAR IN 2008. HE CURRENTLY HAS ONLY 5 ACTIVE CHANNELS IN HIS MAP DUE TO INADEQUATE LOUDNESS GROWTH. IT IS REPORTED THAT THE PT HAS ALWAYS HAD AUDITORY DETECTION WITH HIS COCHLEAR IMPLANT SOUND PROCESSOR, BUT POOR SPEECH PERCEPTION PERFORMANCE (LAST DOCUMENTED IN MAY 2012, 29% ON HINT SENTENCES). A CT SCAN WAS REPORTEDLY RECENTLY DONE AND SHOWED A FULL INSERTION OF THE SONATA STANDARD ARRAY. TESTING WAS PERFORMED TO EVALUATE THE INTEGRITY OF THE IMPLANT, WHICH DID NOT REVEAL ANY SIGNIFICANT INTERMITTENCIES OR FLUCTUATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR