BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1034494 · Received April 28, 2008

    Report

    Report Number
    9710014-2008-00138
    Event Type
    Malfunction
    Date Received
    April 28, 2008
    Date of Event
    April 22, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 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 PT'S WIFE CALLED MED-EL CORP LAST WEEK AND SAID THAT SHE THOUGHT HER HUSBAND'S DEVICE WAS FAILING. THE PT'S CI AUDIOLOGIST CALLED IN 2007, TO REPORT AN INTERNAL DEVICE FAILURE AS EVIDENCED BY TESTING.

    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 61 YR