BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 4180415 · Received October 15, 2014

    Report

    Report Number
    9710014-2014-00534
    Event Type
    Injury
    Date Received
    October 15, 2014
    Date of Event
    September 12, 2014
    Report Date
    August 31, 2015
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    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 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 PT SUFFERED A BLOW TO THE IMPLANTED SIDE OF THE HEAD AND LOST ACCESS TO SOUND. REVISION SURGERY HAS NOT BEEN YET DECIDED UPON DUE TO PT'S AGE AND MEDICAL CONDITIONS. THE AUDIOLOGIST HAS FITTED THE CONTRA-LATERAL SIDE WITH A HEARING AID TO GIVE THE PT SOME AUDIBLE INPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654278 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention