BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2133497 · Received June 15, 2011

    Report

    Report Number
    9710014-2011-00183
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 9, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD 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 AT (B)(6), THE PT HAD SOME PROBLEMS WITH HEARING WITH THE CI. THERE WERE SOME DISCONNECTIONS IN HEARING. AT THE END OF THE WEEK SHE COULD NO LONGER HEAR WITH THE DEVICE AT ALL. EXTERNAL PARTS HAVE BEEN CHANGED, BUT NO HEARING COULD BE ACHIEVED. TESTING CARRIED OUT ON (B)(6) 2011 SHOWED THAT THE DEVICE HAS MALFUNCTIONED. NO TRAUMA/ACCIDENT HAS HAPPENED. THE PT WAS REIMPLANTED ON (B)(6) 2011.

    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 17 YR Required Intervention