BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2012333 · Received February 1, 2011

    Report

    Report Number
    9710014-2011-00034
    Event Type
    Malfunction
    Date Received
    February 1, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 31, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 FELL AT SCHOOL AND BANGED HER HEAD. FOLLOWING THIS EPISODE, SHE EXPERIENCED SEVERE SWELLING AT THE IMPLANT SITE. SHE HAS NOT BEEN ABLE TO HEAR ANYTHING FROM HER LEFT SIDE SINCE. HER PROCESSOR HAS BEEN CHECKED AND REPLACED. TESTING PERFORMED AT THE CLINIC CONFIRMED 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 PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR