BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3930038 · Received March 10, 2014

    Report

    Report Number
    9710014-2014-00120
    Event Type
    Malfunction
    Date Received
    March 10, 2014
    Date of Event
    August 14, 2013
    Report Date
    February 26, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 HAD A CONTROL APPOINTMENT ON (B)(6) 2013, DURING WHICH TWO ELECTRODE CHANNELS WERE FOUND WITH HI STATUS. THESE CHANNELS WERE DISABLED. THERE HAS BEEN NO DETRIMENT TO THE PATIENT'S PERFORMANCE. AS PER THE NEW INFORMATION RECEIVED ON (B)(6) 2014, TWO ADDITIONAL ELECTRODE CHANNELS ARE SHOWING STATUS HI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143622 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM CONCERTO PIN +FLEX28 MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR