BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3002191 · Received February 11, 2013

    Report

    Report Number
    9710014-2013-00047
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 4, 2013
    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 CLINIC STATED THAT THE PT HAD COMPLAINED THAT THE PERFORMANCE OF THE DEVICE HAD DETERIORATED RAPIDLY OVER THE PAST WEEK. THERE IS ONLY A VERY WEAK OUTPUT FROM THE SPEECH PROCESSOR WHICH IS DISTORTED AND OCCASIONALLY THERE IS NO OUTPUT AT ALL. THE PT HAD 3 FALLS PRIOR TO (B)(6) 2012 AND ON AT LEAST ONE OCCASION HE WAS KNOWN TO HAVE BANGED HIS HEAD. IT IS NOT KNOWN HOW HARD OR WHERE ON HIS HEAD THE CONTACT WAS MADE. A FEW WEEKS AFTER THIS INCIDENT HE NOTICED THAT HIS PERCEPTION OF SOUND WAS REDUCED AND DISTORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59743 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR