BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1172534 · Received September 23, 2008

    Report

    Report Number
    9710014-2008-00300
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Report Date
    September 11, 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 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 PATIENT HAD REPORTEDLY ACCIDENTALLY UNDERGONE A MRI SCAN FOR HER BACK. THE REQUESTING PHYSICIAN HAD ASKED FOR A CAT SCAN. FIELD STRENGTH OF THE MRI WAS 1.5T. PATIENT IS NOW COMPLAINING ABOUT DIZZINESS AND STATIC SOUND, THOUGH SHE DOES REPORT THAT SHE IS STILL ABLE TO USE HER 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 C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR