BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2002293 · Received January 27, 2011

    Report

    Report Number
    9710014-2011-00023
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 8, 2011
    Report Date
    January 25, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 THE PT BEGAN EXPERIENCING INTERMITTENT MUFFLED SOUND QUALITY ON SATURDAY, (B)(6) 2011. ON MONDAY SHE CALLED TO REQUEST A NEW CABLE. ON (B)(6), SHE REPORTED THAT THE NEW CABLE DID NOT IMPROVE SOUND QUALITY. SHE ALSO TRIED A NEW COIL AND USING A BACK-UP PROCESSOR WITHOUT IMPROVEMENT. IN ADDITION, SHE HAS BEGUN EXPERIENCING A LOUD HIGH-PITCHED NOISE AND POPPING SENSATION WHEN SHE TRIES TO USE HER PROCESSOR. SHE ALSO DESCRIBES FEELING PULSES. SHE DOES HAVE AN EARACHE THAT BEGAN SATURDAY AROUND THE SAME TIME THAT THE MUFFLED SOUND BEGAN. THIS DEVELOPED INTO A SEVERE HEAD PAIN FROM THE LEFT SIDE EXTENDING DOWN TO HER JAW. THE PT ATTENDED THE ER AND THE PT WAS DIAGNOSED WITH TMJ AND PRESCRIBED PAIN KILLERS (PT WAS AWARE OF THIS FROM A PREVIOUS DIAGNOSIS). THE PT CEASED WEARING HER LEFT SPEECH PROCESSOR ON (B)(6) AND TWO DAYS LATER THE HEAD PAIN CEASED. TESTING CARRIED OUT ON (B)(6) 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 C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR