BEUDAMED
    FDA Adverse Event Other Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 3070210 · Received April 16, 2013

    Report

    Report Number
    9710014-2013-00141
    Event Type
    Other
    Date Received
    April 16, 2013
    Date of Event
    January 1, 2013
    Report Date
    April 11, 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 MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF SWELLING OVER INTERNAL RECEIVE-STIMULATOR, WHICH WAS DIAGNOSED AS AN INFECTION. PATIENT STOPPED WEARING THE DEVICE AND RECEIVED ANTIBIOTIC TREATMENT, WHICH APPEARED TO IMPROVE SYMPTOMS. PATIENT BEGAN WEARING THE DEVICE AGAIN AND SYMPTOMS REOCCURRED. THE PATIENT IS SCHEDULED TO BE EXPLANTED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164006 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM SONATA STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR