BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2093044 · Received April 15, 2011

    Report

    Report Number
    9710014-2011-00125
    Event Type
    Malfunction
    Date Received
    April 15, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 13, 2011
    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

    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 AROUND ONE MONTH AGO PATIENT BEGUN TO FEEL PAIN, DISTORTION OF SOUND AND ¿SHORT CIRCUIT SENSATION¿. ON (B)(6) 2011, SHE WAS NO LONGER ABLE TO HEAR. EXTERNAL PARTS ARE OK. TESTING CONFIRMED THAT THE DEVICE IS NO LONGER WORKING WITHIN SPECIFICATION.

    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