BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1399489 · Received April 14, 2009

    Report

    Report Number
    9710014-2009-00125
    Event Type
    Malfunction
    Date Received
    April 14, 2009
    Date of Event
    March 16, 2009
    Report Date
    April 1, 2009
    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 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 CALLED HER AUDIOLOGIST COMPLAINING THAT SHE WAS HAVING ISSUES WITH HER SPEECH PROCESSOR AND WAS EXPERIENCING POPPING NOISES AND STATIC. THE PATIENT WAS SHIPPED AN ENTIRE LOANER IMPLANT SYSTEM FROM THE AUDIOLOGIST'S CLINIC STOCK. THE PATIENT RECEIVED THE LOANER EQUIPMENT ON MARCH 18 AND AFTER USING IT, COMPLAINED THAT THE STATIC AND POPPING NOISES WERE STILL OCCURRING. THE PATIENT IS ALSO STRUGGLING TO UNDERSTAND SPEECH AND WAKES UP WITH A HEADACHE EVERY MORNING. UPON RECEIPT OF THIS INFORMATION ON MARCH 19, MED-EL CORP SENT A NEW CABLE TO THE PATIENT. UNFORTUNATELY, THE REPLACEMENT CABLE HAD NO EFFECT ON HER SITUATION. THE PATIENT'S CLINICIAN FEELS THAT IT IS AN INTERNAL DEVICE FAILURE. THE PATIENT WILL NOT BE ABLE TO ATTEND THE CLINIC UNTIL MID-APRIL.

    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 63 YR