BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2050777 · Received March 31, 2011

    Report

    Report Number
    9710014-2011-00109
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    January 1, 2010
    Report Date
    March 28, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. WHEN AVAILABLE, A DEVICE ANALYSIS WILL BE SUBMITTED AS A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS SEEN BY MED-EL DUE TO REPORTS OF TINNITUS/HEADACHE. THE PT HAS REPORTEDLY TRIED USING HIS SPEECH PROCESSOR ON A NUMBER OF OCCASIONS, BUT HAS TO REMOVE IT DUE TO HIM EXPERIENCING THE SOUND AS UNCOMFORTABLY LOUD AND CAUSING HEADACHES ALONG WITH A SENSATION OF DIZZINESS. AN ATYPICAL TINNITUS IS REPORTED TO OCCUR APPROX 10-20 TIMES PER DAY. THIS IS REPORTED TO OCCUR BOTH WHEN USING AND NOT USING THE PROCESSOR. NO DEVICE RELATED EXPLANATION FOUND. TESTING IS CONSISTENT WITH NORMAL DEVICE FUNCTION. RE-MAPPING HAS BEEN CARRIED OUT BUT THE PT HAS NOT SHOWN ANY PROGRESS.

    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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention