BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SSYTEM

    MDR report key: 3013072 · Received March 15, 2013

    Report

    Report Number
    9710014-2013-00100
    Event Type
    Malfunction
    Date Received
    March 15, 2013
    Report Date
    March 11, 2013
    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 EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT COMPLAINED ABOUT A STRONG BACKGROUND NOISE PROBLEM WITH HIS LEFT PROCESSOR SINCE (B)(6). ALL EXTERNAL PARTS WERE CHECKED. THE DIB COIL RETAINED SATISFACTORILY AND THE SKIN FLAP APPEARED TO BE HEALTHY. NO ACCIDENT OR TRAUMA WERE REPORTED. THE PT WAS ADVISED NOT TO USE THE PROCESSOR ANYMORE. RE-IMPLANTATION SURGERY IS SCHEDULED FOR (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110305 MED-EL COMBI 40+ COCHLEAR IMPLANT SSYTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR