BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3122098 · Received May 16, 2013

    Report

    Report Number
    9710014-2013-00193
    Event Type
    Injury
    Date Received
    May 16, 2013
    Report Date
    May 10, 2013
    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 INNSBRUCK WHERE IT WILL BE EVALUATED. 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 ELECTRODE LEAD WAS FOUND IN THE OUTER EAR CANAL ON (B)(6) 2013 DURING EAR WAX REMOVAL. THE PT REPORTED AN OBVIOUS DECLINE IN HIS HEARING PERFORMANCE. THE PT WAS RE-IMPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217511 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ COMPRESSED MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention