BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2100423 · Received May 13, 2011

    Report

    Report Number
    9710014-2011-00154
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    February 9, 2011
    Report Date
    May 10, 2011
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS NO LONGER ABLE TO HEAR WITH HER DEVICE. TESTING SHOWED ALL CHANNELS IN STATUS HI. THE GROUND PATH IMPEDANCE (GPI) WAS NOT RECORDABLE. AN X-RAY REVEALED THE CLOVER LEAF OF THE GROUND ELECTRODE TO BE BROKEN. A HISTORY OF HEAD TRAUMA WAS NOT REPORTED BY THE PARENTS. THE PT WAS RE-IMPLANTED ON (B)(6) 2011.

    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 3 YR Required Intervention