BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2093338 · Received April 19, 2011

    Report

    Report Number
    9710014-2011-00129
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 18, 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 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 WHEN THE PT TURNS THE HEAD TO THE LEFT SHE IS UNABLE TO HEAR ANYTHING. TESTING ON (B)(6) 2011, SHOWED THAT 3 ELECTRODE CHANNELS ARE HI. EARLIER IN (B)(6) 2011 THE PT WAS TAKEN TO HOSPITAL FOR SEVERE DIZZINESS. IT IS NOT KNOWN IF THE PT IS DIZZY WITH AND/OR WITHOUT HER IMPLANT. THE PT HAS HAD A FEW BALANCE ISSUES FOR ABOUT A YEAR AND A HALF, BUT DENIES HITTING HER HEAD AROUND THE IMPLANT.

    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 84 YR