BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2100461 · Received May 17, 2011

    Report

    Report Number
    9710014-2011-00161
    Event Type
    Injury
    Date Received
    May 17, 2011
    Report Date
    May 13, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MFR FOR EVAL. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NO LONGER ABLE TO HEAR WITH HIS DEVICE. THE ELECTRODES CHANNELS WENT PROGRESSIVELY INTO HIGH IMPEDANCE. TESTING CARRIED OUT ON (B)(6) 2011, SHOWS CHANNELS 1, 2, 3, 4, 6, 7, AND 11 IN STATUS HI. THE PT 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 4 YR Required Intervention