BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1082291 · Received July 29, 2008

    Report

    Report Number
    9710014-2008-00238
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 15, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 AN ATTEMPT TO RE-POSITION THE PATIENT'S COCHLEAR IMPLANT, AS WELL AS SHAVE DOWN THE PATIENT'S SKIN FLAP, A PORTION OF THE ELECTRODE WAS ACCIDENTALLY WITHDRAWN FROM THE COCHLEAR. THE INCIDENT WAS REPORTED TO MED-EL CORP BY THE CLINICIAN, ALONG WITH AN ORDER FOR A NEW IMPLANT FOR THIS PATIENT. IN 2008, THE SURGEON RE-IMPLANTED THE PATIENT WITH THE NEW DEVICE WHICH HAD BEEN SHIPPED. THE ORIGINAL REVISION ATTEMPT HAD NOT BEEN REPORTED TO MED-EL PRIOR TO IT TAKING PLACE. THE RESULTING NECESSITY TO EXPLANT/RE-IMPLANT WAS DUE TO THE SURGEON'S ERROR DURING THE PREVIOUS REVISION ATTEMPT AND WAS IN NO WAY THE FAULT OF THE 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 SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention