BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2050778 · Received March 31, 2011

    Report

    Report Number
    9710014-2011-00110
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 25, 2011
    Report Date
    March 28, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CHECK-UP APPOINTMENT A CONSIDERABLE AMOUNT OF CERUMEN WAS FOUND IN THE RADICAL CAVITY. DURING SUCTION CLEANING IT WAS DISCOVERED THAT PART OF THE ACTIVE ELECTRODE WAS LYING UNCOVERED IN A LOOP SHAPE IN THE MIDDLE EAR. THE ACTIVE ELECTRODE WAS PARTIALLY PULLED OUT OF THE COCHLEA DURING THE CLEANING PROCESS. AFTER THE CLEANING PROCESS THE DEVICE WAS TESTED, AND IT SHOWED NORMAL VALUES. THE PATIENT DESCRIBES HIS HEARING IMPRESSION AS A FIZZLING NOISE. THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2011.

    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 90 YR Required Intervention