BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1934689 · Received November 26, 2010

    Report

    Report Number
    9710014-2010-00379
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Date of Event
    November 2, 2010
    Report Date
    November 24, 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 F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT VISITED HIS HOSPITAL TO RECEIVE A SECOND OPINION ABOUT HIS IMPLANT PERFORMANCE. HE WAS IMPLANTED IN A DIFFERENT HOSPITAL. THE ENT DEPARTMENT DIAGNOSED A NON-APPROPRIATE PLACEMENT OF THE ELECTRODE ARRAY AND SUGGESTED TO RE-IMPLANT THE PT. THE PT ACCEPTED THE PROPOSAL. TESTING SHOWS THAT HE IMPLANT IS WORKING UNDER SPECIFICATIONS.

    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 UNK