BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1812549 · Received August 10, 2010

    Report

    Report Number
    9710014-2010-00245
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    July 30, 2010
    Report Date
    August 6, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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 F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6), 2010, THE PT HEARD SOME CRACKLING NOISES FROM HER COCHLEA IMPLANT FOR THE FIRST TIME. THEN THE IMPLANT BECAME INTERMITTENT DURING THE DAY AND EVENTUALLY STOPPED WORKING. SINCE THEN THE PT HAS HAD NO ACCESS TO SOUND. THE EXTERNAL EQUIPMENT WAS REPLACED BUT THE PT WAS STILL UNABLE TO HEAR. TESTING CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED.

    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 PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR