BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1051879 · Received May 13, 2008

    Report

    Report Number
    9710014-2008-00166
    Event Type
    Malfunction
    Date Received
    May 13, 2008
    Date of Event
    April 1, 2008
    Report Date
    May 13, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 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 DURING ROUTINE TESTING, IT WAS FOUND THAT 6 ELECTRODE CHANNELS HAVE HIGH IMPEDANCES. THE PARENTS THEN MENTIONED THAT THE CHILD HIT HER HEAD SOME DAYS AGO, WHILE PLAYING WITH HER SISTER. THERE ARE NO VISIBLE INJURIES ON THE CHILD'S HEAD. AS THE PT WAS FIRST ACTIVATED IN EARLY 2008, THE PARENTS DID NOT NOTICE ANY SHORTFALL IN THE FUNCTIONALITY OF THE IMPLANT SYSTEM. ON FOUR MONTHS LATER, ADD'L TESTING WAS CARRIED OUT, WHICH SHOWED 10 CHANNELS HAVING HIGH IMPEDANCES.

    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 30 MO