BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1934666 · Received November 26, 2010

    Report

    Report Number
    9710014-2010-00385
    Event Type
    Malfunction
    Date Received
    November 26, 2010
    Date of Event
    November 22, 2010
    Report Date
    November 24, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IS SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MANUFACTURER 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 TESTING REVEALED: GROUND PATH IMPEDANCE, FOUR SHORT CIRCUITS (ELECTRODES 4, 5, 10 AND 11) AND THREE ELECTRODES IN STATUS HI (1,3, AND 12). LAST TESTING CARRIED OUT ON (B)(6) 2010 SHOWED ALL 12 ELECTRODES IN STATUS OK. THE PARENTS STATED THAT THEY WERE NOT AWARE OF ANY RECENT FALLS OR BLOWS TO THE HEAD. HOWEVER, THE CLINICIAN NOTICED BLOOD ALONG THE TOP OF THE INCISION SITE AT THE CLINIC VISIT ON (B)(6) 2010. THE PT HAD NOT WORN A PROCESSOR SINCE AUGUST OF THIS YEAR AS SHE HAS LOST HER SPEECH PROCESSOR. WHEN USING THE RECENTLY OBTAINED REPLACEMENT PROCESSOR, THE PT ONLY GOT SOME AUDITORY DETECTION BUT NOT USABLE SPEECH DISCRIMINATION. THE PT HAS CUSTOM MADE DEVICE FOR A COMMON CAVITY.

    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