BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40 + COCHLEAR IMPLANT SYSTEM

    MDR report key: 3072649 · Received April 19, 2013

    Report

    Report Number
    9710014-2013-00147
    Event Type
    Malfunction
    Date Received
    April 19, 2013
    Report Date
    April 17, 2013
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 WAS IMPLANTED IN (B)(6) 2006 AND BENEFITED FROM HIS DEVICE. LATEST TESTING IN SITU SHOWED 8 ELECTRODE CHANNELS IN STATUS HI AND 2 ELECTRODE CHANNELS IN STATUS S/C. NO ACCIDENT OR TRAUMA IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169810 MED-EL COMBI 40 + COCHLEAR IMPLANT SYSTEM PULSAR STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR