BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 4840413 · Received June 11, 2015

    Report

    Report Number
    9710014-2015-00418
    Event Type
    Injury
    Date Received
    June 11, 2015
    Date of Event
    December 24, 2014
    Report Date
    September 16, 2015
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD 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.

    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. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN SITU MEASUREMENTS SHOWED 7 ELECTRODE CHANNELS WITH STATUS HI AND ANOTHER 2 WITH SC. AN ACCIDENT OR TRAUMA IS NOT KNOWN. A CT SCAN SHOWED NORMAL RESULTS. REPORTEDLY WHEN INITIALLY INFORMED THE PARENTS REFUSED FURTHER F/U DUE TO CONCERNS ABOUT CORONAVIRUS. NOW THEY ARE READY TO PROCEED WITH RE-IMPLANTATION SHOULD IT BE DECIDED BY THE SURGEON. RE-IMPLANTATION IS TO BE PERFORMED ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN-SITU MEASUREMENTS SHOWED 7 CHANNELS WITH HIGH IMPEDANCES AND 2 CHANNELS IN A SHORT CIRCUIT. AN ACCIDENT OR TRAUMA IS NOT KNOWN AND A CT SCAN SHOWED NORMAL RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381904 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention