BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1870866 · Received October 7, 2010

    Report

    Report Number
    9710014-2010-00323
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    July 15, 2010
    Report Date
    October 7, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND HAS BEEN RETURNED TO THE MANUFACTURER WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SKIN FLAP OVER THE IMPLANT WAS DAMAGED WITH A PURULENT DISCHARGE, WHICH IMPROVED SOMEWHAT WITH ANTIBIOTICS. GRANULATED TISSUE FILLED THE WHOLE BED OF THE IMPLANT. THE PATIENT WAS EXPLANTED ON (B)(6) 2010.

    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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention