BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3063637 · Received April 12, 2013

    Report

    Report Number
    9710014-2013-00127
    Event Type
    Malfunction
    Date Received
    April 12, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 5, 2013
    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, IMPLANTED ON (B)(6) 1998, HEARS STEADY BACKGROUND NOISES. THE VOLUME IS ALTERNATING BETWEEN LOUD AND NORMAL VOLUME. THE EXTERNAL PARTS WERE REPLACED AND THE SITUATION REMAINED UNCHANGED. RE-IMPLANTATION SURGERY IS SCHEDULED FOR (B)(6), 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159386 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR