BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1082331 · Received July 29, 2008

    Report

    Report Number
    9710014-2008-00228
    Event Type
    Malfunction
    Date Received
    July 29, 2008
    Date of Event
    January 1, 2008
    Report Date
    July 7, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 ATTENDED THE CLINIC TO EXCHANGE HER TEMPO+ SPEECH PROCESSOR TO THE NEW OPUS 2 SPEECH PROCESSOR. TESTING CARRIED OUT AT THE TIME SHOWED THAT 10 OF THE ELECTRODE CHANNELS OF THE ELECTRODE ARRAY HAD HIGH IMPEDANCES. ONLY 2 CHANNELS WERE OK. HISTORICALLY THERE HAS BEEN A PROGRESSIVE DAMAGE OF THE ELECTRODE ARRAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR