BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ CPCHLEAR IMPLANT SYSTEM

    MDR report key: 1556194 · Received December 2, 2009

    Report

    Report Number
    9710014-2009-00418
    Event Type
    Malfunction
    Date Received
    December 2, 2009
    Date of Event
    August 1, 2009
    Report Date
    November 26, 2009
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    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 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 3 MONTHS AGO THE PT'S PARENTS FOUND THAT THE CHILD COULD NOT RESPOND VERY WELL, EVEN THOUGH THE BTE DEVICE WAS IN GOOD CONDITION. IN THE MORNING THE PARENTS CHECKED THE DEVICE AND TESTED THE CHILD'S RESPONSE, WHICH WAS VERY GOOD. BUT WHEN THE PARENTS SAW THE TEACHER, HE REPORTED THAT IT WAS BAD. TESTING REVEALED 9 CHANNELS WITH THE STATUS HI AND NO GROUNDPATH IMPEDANCE, SHOWING THAT THE DEVICE HAS MALFUNCTIONED. ONLY 1 CHANNEL CAN BE HEARD. PREVIOUS TESTING IN (B)(6) 2008, HAD SHOWN ALL CHANNELS WITH THE STATUS OK. IN (B)(6) 2009, TESTING HAD REVEALED 1 CHANNEL WITH THE STATUS HI. THE PARENTS DIDN'T REPORT CLEARLY ABOUT AN ACCIDENT. BUT THEY SAID THAT SOMETIME 2 BROTHERS HIT EACH OTHER, AND MAYBE THEIR CHILD FELL OR HIT SOMEWHERE WHEN HE WENT TO THE KINDERGARTEN, BUT THEY ARE NOT SURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ CPCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR