BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 4840412 · Received June 11, 2015

    Report

    Report Number
    9710014-2015-00414
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    May 13, 2015
    Report Date
    November 5, 2015
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DAMAGE TO THE ACTIVE ELECTRODE, AS MIGHT BE CAUSED BY AN EXTERNAL MECHANICAL IMPACT, WAS DETERMINED TO BE THE ROOT CAUSE OF DEVICE FAILURE. THE PROBLEMS GIVEN IN THE PATIENT REPORT APPEAR TO MATCH THE DAMAGE FOUND. ADDITIONALLY THE DEVICE WAS IMPLANTED UPSIDE DOWN, HOWEVER THIS WAS NOT THE REASON FOR EXPLANTATION. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO 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 SINCE FIRST FITTING THE AUDIOLOGIST REALIZED THAT THE IMPLANT WAS FIXED UPSIDE DOWN AND THAT A CMD COIL WAS GOING TO BE REQUESTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SINCE FIRST FITTING THE AUDIOLOGIST REALIZED THAT THE IMPLANT WAS FIXED UPSIDE DOWN AND THAT A CMD COIL WAS GOING TO BE REQUESTED. THE DEVICE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383355 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention