BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1820129 · Received August 23, 2010

    Report

    Report Number
    9710014-2010-00263
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Report Date
    August 18, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 FAILURE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT IS NOT LONGER ABLE TO HEAR WITH HER DEVICE FOR SOME TIME. BY MISTAKE SHE HAD CHANGED HER PROGRAM WITH THE REMOTE CONTROL, SO THAT SHE HARDLY COULD HEAR SOUND. AS SHE HAD SEVERAL SURGERIES, SHE HAS BEEN IN BAD GENERAL CONDITION AND, THEREFORE, NO RE-FITTING WAS POSSIBLE FOR A LONG TIME. THEN FITTING WAS RECTIFIED, BUT THAT DIDN'T IMPROVE. TESTING RESULTS ARE UNREMARKABLE. WITH ART MEASUREMENT NO RESPONSE OF THE AUDITORY NERVE COULD BE SHOWN. THE EXTERNAL PARTS WERE CHECKED AND FOUND OK. AUDIOLOGICALLY OR MEDICALLY THERE IS NO CAUSE KNOWN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR