BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2093880 · Received April 6, 2011

    Report

    Report Number
    9710014-2011-00111
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 28, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 PATIENT COMPLAINS ABOUT INCREASING NOISE AND FLUCTUATING HEARING SENSATION SINCE BEGINNING OF (B)(6). ON (B)(6) 2011, THE EXTERNAL PARTS WERE EXCHANGED COMPLETELY AND A NEW FITTING WAS TRIED BUT W/O IMPROVEMENT. BY NOW, THE RANDOM NOISE RESTRAINS THE PATIENT'S SPEECH UNDERSTANDING VERY MUCH. FURTHER THE PATIENT REPORTS A CRACKLING NOISE, WHEN HE HAS THE SPEECH PROCESSOR OFF AND GIVES SLIGHT PRESSURE TO THE AREA AROUND THE IMPLANT. TESTING CARRIED OUT ON (B)(6) 2011 SHOWED A FLUCTUATING GROUNDPATH IMPEDANCE BETWEEN 2.61 KOHM AND 3.09 KOHM. THE VOLTAGE MATRIX SHOWED SOME IRREGULAR VALUES. THE ELECTRODES 9 AND 12 SHOWED IMPEDANCE FLUCTUATIONS BY 5 KOHM, WHEN PRESSURE WAS GIVEN TO THE AREA AROUND THE IMPLANT - WHILE THE PATIENT EXPERIENCED A CRACKLING NOISE. AN ACCIDENT OR FALL HAS NOT BEEN REPORTED.

    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 C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR