BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2120099 · Received June 7, 2011

    Report

    Report Number
    9710014-2011-00176
    Event Type
    Injury
    Date Received
    June 7, 2011
    Report Date
    June 6, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A FITTING APPOINTMENT THE AUDIOLOGIST RECOGNIZED THAT THE IMPLANT WAS NO LONGER FUNCTIONAL. THE PT'S PARENTS DID NOT REPORT ABOUT ANY ACCIDENT. TESTING CARRIED OUT ON (B)(6), 2011 SHOWS 7 ELECTRODE CHANNELS IN STATUS HI AND 2 ELECTRODE CHANNELS IN STATUS SC. 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