BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1122352 · Received August 18, 2008

    Report

    Report Number
    9710014-2008-00263
    Event Type
    Malfunction
    Date Received
    August 18, 2008
    Date of Event
    July 1, 2008
    Report Date
    August 8, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 BY THE PATIENT'S FAMILY THAT THE PATIENT HAD A HEAD TRAUMA. THE FIRST ONE HAS BEEN ON THE FOREHEAD AND THE SECOND ONE HAS BEEN ON THE NON-IMPLANTED SIDE. AFTER A WHILE THE PATIENT'S HEARING SENSATION DECREASED. INITIAL TESTING SHOWED A FEW HIGH CHANNELS. FITTING MAP HAS BEEN ADAPTED ACCORDING TO TESTING. LATEST TESTING RESULTS OF 2008 SHOWED CHANNELS 1, 2, 6, 9, 11, AND 12 WITH STATUS HIGH AND A SHORT CIRCUIT BETWEEN CHANNELS 7 AND 10 .

    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 5 YR