BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1172535 · Received September 23, 2008

    Report

    Report Number
    9710014-2008-00302
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 10, 2008
    Report Date
    September 12, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 ACCORDING TO THE FAMILY THE PATIENT RECEIVED A BLOW TO THE IMPLANT AREA ONE WEEK AGO. FROM THEN ON HE HAS NO LONGER BEEN ABLE TO HEAR WITH HIS DEVICE. THE PROCESSOR WAS DOUBLE CHECKED AND WORKED FINE. TESTING WAS CARRIED OUT WHICH CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED. RE-IMPLANTATION SURGERY IS SCHEDULED FOR 2008.

    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 PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR