BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6085182 · Received November 8, 2016

    Report

    Report Number
    9710014-2016-00754
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    October 31, 2016
    Report Date
    March 1, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    CONCLUSION: THE DEVICE INVESTIGATION CONFIRMED A DEFECTIVE CONTACT AT THE WELDING JOINT BETWEEN FEEDTHROUGH PIN AND IMPLANT COIL. THE PROBLEMS DESCRIBED IN THE PATIENT REPORT APPEAR TO MATCH THE DAMAGE FOUND. THIS IS A FINAL REPORT.

    Description of Event or Problem · 1

    PATIENT HAS NO HEARING SENSATIONS WITH THE DEVICE.

    Description of Event or Problem · 1

    PATIENT HAS NO HEARING SENSATIONS WITH THE DEVICE. IN SITU MEASUREMENT WAS INDICATIVE OF A DEVICE MALFUNCTION. RE-IMPLANTATION IS SCHEDULED. THE PATIENT WAS RE-IMPLANTED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737805 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 83 YR Required Intervention