BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 962360 · Received May 3, 2007

    Report

    Report Number
    9710014-2007-00114
    Event Type
    Malfunction
    Date Received
    May 3, 2007
    Date of Event
    January 1, 2007
    Report Date
    May 2, 2007
    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'S AUDIOLOGIST CONTACTED MED-EL CORP REGARDING RISING IMPEDANCES ACROSS THE ELECTRODE ARRAY AND TWO CHANNELS WITH HI'S. A REVIEW OF PREVIOUS TESTING REVEALED A STABLE GROUND PATH IMPEDANCE (2.25) AND CONFIRMED THAT IMPEDANCES HAVE INCREASED OVER THE LAST THREE RECORDINGS. INITIALLY ALL IMPEDANCES WERE WITHIN NORMAL LIMITS, THEN AN INCREASE WITH ONE HI, AND NOW AT TODAY'S APPOINTMENT, A SECOND HI WAS OBSERVED.

    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 5 YR