BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYS

    MDR report key: 3960016 · Received May 29, 2014

    Report

    Report Number
    9710014-2014-00261
    Event Type
    Malfunction
    Date Received
    May 29, 2014
    Date of Event
    December 23, 2013
    Report Date
    May 17, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    AN OBVIOUS DECLINE IN THE PT'S HEARING PERFORMANCE WAS NOTICED ON (B)(6) 2013. THE PT WAS REIMPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316167 MED-EL COMBI 40+ COCHLEAR IMPLANT SYS C40+ MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Required Intervention