BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1030318 · Received April 16, 2008

    Report

    Report Number
    9710014-2008-00121
    Event Type
    Malfunction
    Date Received
    April 16, 2008
    Date of Event
    January 1, 2007
    Report Date
    April 9, 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 PT HAS NOT BEEN WEARING HIS DEVICE FOR THE PAST 4 MONTHS, AS, ACCORDING TO THE PARENTS, THIS WAS DUE TO A BAD BATCH OF BATTERIES. HOWEVER, THE PT ATTENDS A SCHOOL FOR THE DEAF AND IT SEEMS THAT THE SCHOOL FOR THE DEAF DOES NOT MAKE THE CHILD WEAR THE DEVICE. THE PT HAS NOT BEEN SEEN AT THE CLINIC SINCE 2006. THERE HAVE BEEN MULTIPLE NO SHOWS FOR APPOINTMENTS. THE CHILD REPEATEDLY HITS HIS HEAD. TESTING CARRIED OUT BY THE CLINIC SHOW THAT THE DEVICE HAS MALFUNCTIONED. FURTHER TESTING IS DUE TO BE CARRIED OUT IN 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 32 MO