BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1913817 · Received November 26, 2010

    Report

    Report Number
    9710014-2010-00386
    Event Type
    Injury
    Date Received
    November 26, 2010
    Date of Event
    November 12, 2010
    Report Date
    November 25, 2010
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6), 2010, THE PATIENT SUDDENLY WAS NO LONGER ABLE TO HEAR WITH HER CI. CHECKING THE PROCESSOR ON (B)(6), 2010 DID NOT IMPROVE. THEN THE IMPLANT WAS CHECKED AND TESTING SHOWED THAT THE DEVICE HAS MALFUNCTIONED. THERE IS NO ACCIDENT KNOWN. THE PATIENT WAS REIMPLANTED ON (B)(6), 2010.

    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 84 YR Required Intervention