BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 3961810 · Received May 5, 2014

    Report

    Report Number
    9710014-2014-00282
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    December 1, 2013
    Report Date
    April 23, 2014
    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 HAS BEEN RETURNED TO MED-EL HEADQUARTERS, WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPLANTED OF HIS COCHLEAR IMPLANT ON (B)(6) 2013, AS THE PT REFUSED-IMPLANTATION. THE PATIENT HAS A RADICAL CAVITY IN WHICH THE ARRAY WAS FOUND EXPOSED WITHOUT ANY SIGN OF INFECTION. THE PT GAVE UP USING IMPLANT, AS RELIED UPON CONTRALATERAL HEARING AID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267908 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention