BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2002294 · Received January 27, 2011

    Report

    Report Number
    9710014-2011-00022
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    December 17, 2010
    Report Date
    January 25, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A HEAD TRAUMA. THE PTS AND THE AUDIOLOGIST REPORTED THAT THE HEARING SENSATION HAS NOT CHANGED SIGNIFICANTLY. TESTING PERFORMED ON (B)(6), 2011 SHOWS ELECTRODE CHANNELS 4, 5, 6, 7, 8, 10, 11 AND 12 IN STATUS HI. ELECTRODE CHANNELS 1 AND 2 ARE IN STATUS SC, AND ELECTRODE CHANNELS 3 AND 9 ARE IN STATUS OK.

    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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR