BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 642607 · Received October 25, 2005

    Report

    Report Number
    9710014-2005-00270
    Event Type
    Injury
    Date Received
    October 25, 2005
    Date of Event
    January 25, 2005
    Report Date
    October 24, 2005
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS TO BE RE-IMPLANTED ON SEPTEMBER 22, 2005 DUE TO IMPROPER POSITIONING OF THE ELECTRODE DURING INITIAL SURGERY WHICH TOOK PLACE ON JANUARY 25, 2005.

    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 C40+ *

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention