BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1424659 · Received April 3, 2009

    Report

    Report Number
    9710014-2009-00133
    Event Type
    Malfunction
    Date Received
    April 3, 2009
    Date of Event
    March 26, 2009
    Report Date
    March 30, 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 YET BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR 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 WAS SEEN AT THE CLINIC FOLLOWING AN ACCIDENT ON THE PLAYGROUND AT SCHOOL. HE WAS REPORTEDLY HIT ON THE HEAD ON THE RIGHT SIDE OVER THE IMPLANT SITE WITH A BALL. HE IMMEDIATELY REPORTED AFTER THE HIT THAT HE COULD NOT HEAR ANYTHING OUT OF HIS RIGHT COCHLEAR IMPLANT. THE PT IS BILATERALLY IMPLANTED. HIS SKIN AROUND THE IMPLANT SITE WAS REPORTEDLY RED FOLLOWING THE HIT. TESTING PERFORMED SHOWED GP IMPEDANCE NOT DETERMINABLE, HI'S ON ALL 12 CHANNELS, COUPLING AND WERE INTEGRITY OK.

    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 10 YR