BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 4101969 · Received September 15, 2014

    Report

    Report Number
    9710014-2014-00459
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 19, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: DAMAGE TO THE ACTIVE ELECTRODE LIKELY CAUSED BY MINUTE DEVICE MOBILITY WAS DETERMINED TO HAVE LED TO DEVICE FAILURE OVER TIME. THE PROBLEMS DESCRIBED IN THE PATIENT REPORT APPEAR TO MATCH THE DAMAGE FOUND. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO 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 IN SITU MEASUREMENTS SHOWED 5 ELECTRODE CHANNELS WITH STATUS HI. IN (B)(6) 2014, THE NUMBER OF ELECTRODE CHANNELS WITH STATUS HI INCREASED TO 9. THERE IS NO REPORT OF AN ACCIDENT OR TRAUMA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN SITU MEASUREMENTS SHOWED 5 ELECTRODE CHANNELS WITH STATUS HI. AN ACCIDENT OR TRAUMA IS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569168 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM CONCERTO PIN +MEDIUM MCM MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention