BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2822491 · Received November 2, 2012

    Report

    Report Number
    9710014-2012-00399
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 31, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED THAT HE WAS NOT ABLE TO HEAR ANYMORE. EXTERNAL DEVICES WERE CHECKED AND FOUND TO BE FUNCTIONAL. TESTING IN SITU SHOWED THAT THE DEVICE HAS MALFUNCTIONED. THE PATIENT WAS RE-IMPLANTED ON (B)(6), 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention