BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1172536 · Received September 23, 2008

    Report

    Report Number
    9710014-2008-00301
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    June 1, 2008
    Report Date
    September 11, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 HAD BAD BRIEF FLUCTUATIONS IN VOLUME WITH NO APPARENT REASON. HE FIRST NOTICED THIS A COUPLE OF MONTHS AGO, THE VOLUME/LOUDNESS WOULD DROP AND THEN RETURN TO NORMAL, USUALLY LASTING ONLY FEW SECONDS TO MINUTES. HE HAS NOTICED THIS HAS OCCURRED WITH A FREQUENCY RANGING FROM A COUPLE OF TIMES A DAY TO ONLY ONCE A WEEK. ALL EXTERNALS HAVE BEEN EXCHANGED, BUT PROBLEM HAS STILL OCCURRED. THE PATIENT ALSO FEELS THAT THE SOUND QUALITY IS NOT AS GOOD AS IT ONCE WAS. HE WAS RECENTLY MAPPED, AND THE MAP PARAMETERS LOOK APPROPRIATE. THERE HAS BEEN NO CHANGE IN MEDICAL HISTORY OR REPORTS OF INJURIES TO THE CI SITE. TESTING CARRIED OUT LAST WEEK ON THIS PATIENT CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED.

    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 C40+

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR