BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3042187 · Received April 4, 2013

    Report

    Report Number
    9710014-2013-00116
    Event Type
    Injury
    Date Received
    April 4, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOUSING OF THE IMPLANT HAD EXTRUDED OUT OF THE SKIN AND THE PATIENT DECIDED TO CUT THE CABLE. THE PATIENT ATTENDED AN APPOINTMENT WITH THE SURGEON. A DECISION WAS MADE BY THE HOSPITAL TO LEAVE THE ELECTRODE ARRAY IN THE COCHLEA AND IMPLANT A NEW DEVICE ON THE CONTRALATERAL SIDE. APPARENTLY, THE PATIENT HAS HAD PREVIOUS SKIN PROBLEMS AT THE IMPLANT AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139326 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM PULSAR STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention