BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1842328 · Received August 30, 2010

    Report

    Report Number
    9710014-2010-00268
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    August 13, 2010
    Report Date
    August 20, 2010
    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 EVAL. 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 HAS BEEN VERY UNSATISFIED WITH HIS HEARING SENSATION SINCE IMPLANTATION. FOR SOME TIME HE COMPLAINS ABOUT A LOUD WOOSHING NOISE, WHICH CAN'T BE CORRECTED BY FITTING. THE ELECTRODES 9-12 ARE SUPPOSED TO BE EXTRA COCHLEA. THEY ARE SWITCHED OFF CURRENTLY. THE ELECTRODES 5 AND 6 HAVE STATUS HI, THE IMPEDANCES ARE FLUCTUATING UPON PRESSURE ON THE COIL. THE PT IS SCHEDULED TO BE REIMPLANTED ON (B)(6), 2010.

    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 50 YR