BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 2860593 · Received December 5, 2012

    Report

    Report Number
    9710014-2012-00431
    Event Type
    Malfunction
    Date Received
    December 5, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 27, 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 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 CONTACTED CLINIC ON (B)(6) 2012, SAYING THAT THEY COULD NO LONGER HEAR SOUND. THE CLINIC SENT REPLACEMENT EXTERNALS TO PATIENT VIA POST. THE PATIENT WAS ABLE TO HEAR FOR ONE HOUR BUT THEN REPORTED LOSS OF SOUND. PATIENT ATTENDED A REPAIR SESSION ON (B)(6) 2012 DURING WHICH THE AUDIOLOGIST REPLACED THE EXTERNALS AGAIN.

    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 47 YR