BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1082302 · Received July 29, 2008

    Report

    Report Number
    9710014-2008-00243
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 16, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 DURING IMPLANTATION, THE SUPRA-MEATAL APPROACH HAD BEEN CHOSEN. DUE TO MULTIPLE INFLAMMATIONS IN THE PATIENT'S OUTER EAR CANAL, THE ACTIVE ELECTRODE EXTRUDED AND WAS LOCATED VISIBLE IN THE OUTER EAR CANAL. TWO REVISION SURGERIES WERE CARRIED OUT TO PLACE THE ELECTRODE BACK. IN THE MEANTIME ONE SHORT CIRCUIT WAS DETECTED. IT WAS DECIDED TO RE-IMPLANT THE PATIENT TO EXCLUDE FURTHER SHORT-CIRCUITS IN THE FUTURE. DURING RE-IMPLANTATION, THE POSTERIOR APPROACH WILL BE TAKEN. THE PATIENT WAS RE-IMPLANTED IN 2008.

    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 27 YR Required Intervention