BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2021423 · Received February 8, 2011

    Report

    Report Number
    9710014-2011-00046
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    January 18, 2011
    Report Date
    May 11, 2016
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    AUDIOLOGIST
    Health Professional
    Yes

    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 FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S MOTHER INFORMED THE AUDIOLOGIST THAT THE PT WAS ON HIS BED, WITHOUT HIS SPEECH PROCESSOR, FEELING AS IF HIS HEAD HAD SWOLLEN UP. AFTER THAT, HE REFUSED TO USE THE SPEECH PROCESSOR BECAUSE OF DISCOMFORT. TESTING CARRIED OUT ON (B)(6) 2011, WAS PERFORMED AFTER THE EVENT WAS REPORTED BY HIS MOTHER. DURING THE CONTROL, THE AUDIOLOGIST DID NOT PERCEIVE ANY ABNORMALITY OF THE IMPLANT AREA AND COIL MAGNET RETENTION WAS NOT AFFECTED. AFTER A NEW FITTING WITH LOWER MCL'S, THE PT DISCOMFORT HAS DISAPPEARED, BUT HIS PERFORMANCE HAS DECREASED. INFLAMMATION OR TRAUMA HAVE BEEN RULED OUT BY THE CLINIC. IT IS KNOWN THAT SINCE 2004 THE REFERENCE ELECTRODE IS DAMAGED (PLEASE REFER TO MDR 9710014-2004-00087).

    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 C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Male Required Intervention