BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1023739 · Received March 31, 2008

    Report

    Report Number
    9710014-2008-00097
    Event Type
    Other
    Date Received
    March 31, 2008
    Date of Event
    January 1, 2007
    Report Date
    March 21, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    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 ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT CURRENTLY ONLY HAS AUDITORY PERCEPTION ON CHANNELS 1-6. PREVIOUSLY SHE HAD PERCEPTION ALSO ON ELECTRODE CHANNELS 7 AND 8. DURING THE IMPLANTATION SURGERY THERE WAS ONLY A 22MM INSERTION ACHIEVED. ACCORDING TO THE PATIENT'S AUDIOLOGIST, A CT SCAN COMPLETED IN THE LAST SIX MONTHS INDICATES THAT ONLY 65 ELECTRODES ARE PRESENTLY IN THE COCHLEAR. THE PT IS SCHEDULED TO UNDERGO EITHER REVISION OR RE-IMPLANTATION SURGERY IN 2008. THERE IS NO REASON TO BELIEVE THAT THE DEVICE IS MALFUNCTIONING BUT THE POOR PLACEMENT AND POTENTIAL MIGRATION IS THE REASON FOR ATTEMPTING TO RE-POSITION OR RE-IMPLANT THE PT.

    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 49 YR