BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1934253 · Received November 23, 2010

    Report

    Report Number
    9710014-2010-00376
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    August 1, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 MANUFACTURER 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 REPORTS THAT HE CANNOT UNDERSTAND ANYTHING WHEREAS BEFOREHAND HE COULD UNDERSTAND EVERYTHING. HIS SPEECH PROCESSOR IS WORKING WELL, ALL EXTERNAL PARTS WERE CHECKED AND THEY ARE FUNCTIONING. HIS SPEECH THERAPIST REPORTS THAT SINCE HIS FIRST FITTING HE WAS UNDERSTANDING VERY WELL DURING THERAPY IN OPEN FIELD, HE WAS USING THE TELEPHONE AND HE DID NOT USE THE HEARING AID ON THE CONTRA-LATERAL SIDE. SINCE (B)(6) 2010, HIS UNDERSTANDING HAS DECREASED AND HE HAS BEEN ABLE TO UNDERSTAND LESS AND LESS. DURING TESTING IT WAS SEEN THAT THERE ARE SEVERAL HI CHANNELS AND TWO MORE CHANNELS WITH A POOR AUDITORY PERCEPTION. THREE ELECTRODE CHANNELS FIRST APPEARED WITH HI IN (B)(6) AND THEN ANOTHER TWO IN (B)(6). AN X-RAY WAS CARRIED OUT AND IT SHOWS THAT PART OF THE ELECTRODE ARRAY IS OUT OF THE COCHLEA.

    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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR