BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2872458 · Received December 11, 2012

    Report

    Report Number
    9710014-2012-00461
    Event Type
    Malfunction
    Date Received
    December 11, 2012
    Date of Event
    November 1, 2012
    Report Date
    December 6, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 CAN NO LONGER HEAR WITH HER DEVICE. SHE HAD PRESENTED WITH A CHOLESTEATOMA IN THE CI WOUND SITE. A SURGERY WAS CARRIED OUT TO REMOVE IT. THE PT WAS REPORTEDLY WELL AND ABLE TO HEAR IMMEDIATELY AFTER THE SURGERY. APPROX 24-36 HOURS LATER, THE PT REPORTED SEVERE VERTIGO AND LOSS OF HEARING VIA THE IMPLANT. THE EXTERNAL PARTS WERE SWAPPED, AND REPROGRAMMING WAS ATTEMPTED WITHOUT SUCCESS. THE PT WAS SEEN BY THE SURGEON, THE BALANCE WAS IMPROVING, BUT SHE STILL WAS NOT ABLE TO HEAR WITH HER CI SYSTEM.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death