BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2043314 · Received February 25, 2011

    Report

    Report Number
    9710014-2011-00064
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 STATED THAT HE HAS AN OBVIOUS DECLINE IN HEARING SINCE (B)(6) 2011. PROBLEMS OF OUTER DEVICES HAVE BEEN EXCLUDED AND HISTORY OF HEAD TRAUMA WAS DENIED BY THE PATIENT AND HIS GUARDIANS. TESTING CARRIED OUT ON (B)(6) 2011 SHOWS, THAT THE DEVICE HAS MALFUNCTIONED.

    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 10 YR