BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2100403 · Received May 13, 2011

    Report

    Report Number
    9710014-2011-00159
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    February 27, 2011
    Report Date
    May 11, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    AUDIOLOGIST

    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 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 THE PT VISITED HIS DOCTOR ON (B)(6) 2011, REPORTING A TRAUMA. THE IMPLANT ZONE BECAME INFLAMED AND A HEMATOMA HAD APPEARED OVER THE DEVICE. A TELEMETRY PERFORMED ON (B)(6) 2011 SHOWED A FUNCTIONAL DEVICE. NOW THERE ARE SKIN ALTERATIONS OVER THE IMPLANT ZONE AND OTORRHEA. HE WAS TREATED WITH ANTIBIOTICS AND CORTICOSTEROIDS WERE ADMINISTERED. THE AREA SCABBED OVER, BECAME LARGER AND BEGAN TO SUPPURATE. PERIODIC INSPECTIONS WITH THE SURGEON WERE PLANNED. A CT SCAN WAS PERFORMED WHICH WAS OK. THE PATIENT IS NO LONGER ABLE TO USE HIS SPEECH PROCESSOR. ADD'L INFO RECEIVED ON (B)(6) 2011 STATED THAT THE PT'S WOUND IS NOW OPEN AND A EXPLANATION WILL BE PERFORMED.

    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 6 YR Required Intervention