BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2241453 · Received August 17, 2011

    Report

    Report Number
    9710014-2011-00246
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    August 8, 2011
    Report Date
    February 9, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: DEVICE INVESTIGATION SHOWS MICRO-LEAKS AT THE HOUSING BRAZE JOINT. THIS LEADS TO THE CONCLUSION THAT THE DEVICE ELECTRONICS FAILED OVER TIME AFTER HUMIDITY INGRESS THROUGH THESE MICRO-LEAKS. THE PROBLEMS DESCRIBED IN THE PATIENT REPORT SEEM TO MATCH THIS FINDING. ADDITIONALLY, DEVICE INVESTIGATION REVEALED DAMAGE TO THE ACTIVE ELECTRODE LIKELY CAUSED BY MINUTE DEVICE MOBILITY. THE PROBLEMS DESCRIBED IN THE PATIENT REPORT APPEAR TO MATCH WITH THE INVESTIGATION FINDINGS. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS NO LONGER ABLE TO HEAR WITH HIS DEVICE. TESTING SHOWS THAT THE DEVICE HAS MALFUNCTIONED.

    Description of Event or Problem · 1

    THE PATIENT SUDDENLY HAD NO ACCESS TO SOUND. THE PATIENT WAS RE-IMPLANTED.

    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 C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention