BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3994416 · Received July 23, 2014

    Report

    Report Number
    9710014-2014-00375
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 16, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    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 MFR FOR EVAL. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ON THE WAY TO THE CLINIC FOR ACTIVATION, WHEN THE PT FELL OFF THE PT'S KNEE ONTO THE FLOOR CAUSING THE IMPLANT WOUND TO REOPEN AND TO START TO BLEED. THE WOUND WAS RE-SUTURED UPON ARRIVING AT THE HOSPITAL. THE PT WILL BE RE-IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431791 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA +STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR