BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1913812 · Received November 26, 2010

    Report

    Report Number
    9710014-2010-00365
    Event Type
    Injury
    Date Received
    November 26, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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 FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DID NOT OBTAIN ANY BENEFIT FROM HIS IMPLANT, BUT HE SUFFERED FROM FACIAL NERVE STIMULATION. AT IMPLANTATION THE ELECTRODE WAS NOT COMPLETELY INSERTED INTO THE COCHLEA. A CT SCAN CARRIED OUT IN (B)(6) 2010 SHOWED A FOLDOVER OUTSIDE THE COCHLEOSTOMY. THE PATIENT WAS RE-IMPLANTED ON (B)(6), 2010 WITH ANOTHER MANUFACTURER'S DEVICE.

    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 15 YR Required Intervention