BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 10746083 · Received October 28, 2020

    Report

    Report Number
    9710014-2020-00621
    Event Type
    Injury
    Date Received
    October 28, 2020
    Report Date
    October 28, 2020
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737062682
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSIONS: AS PER INFORMATION FROM THE FIELD RECIPIENT REPORTED UNCOMFORTABLE SENSATIONS WHEN USING THE DEVICE. IN ADDITION EVOKED ACTION POTENTIAL MEASUREMENTS SHOWED ABNORMAL RESULTS. DEVICE INVESTIGATION CONFIRMED THAT STIMULATOR ELECTRONICS IS WORKING ACCORDING TO SPECIFICATIONS. HOWEVER, A REDUCED ELECTRICAL IMPEDANCE BETWEEN COIL AND EAP/RG (EVOKED ACTION POTENTIALS/ REMOTE GROUND) ELECTRODE WAS DISCOVERED DURING INVESTIGATION, WHICH CAUSED THE REPORTED FAULTY EAP MEASUREMENT RESULTS. A CONTRIBUTION OF THE LOWER-OHMIC CONNECTION BETWEEN COIL AND REFERENCE ELECTRODE TO THE ABNORMAL PERCEPTION CANNOT BE EXCLUDED. IN ADDITION THE RECIPIENT WAS EXPERIENCING STRANGE NOISES EVEN WITHOUT THE AUDIOPROCESSOR SWITCHED ON. IT SEEMS THAT THESE NOISES ARE CAUSED BY TINNITUS, WHICH IS STATED BY THE SURGEON ON THE DEVICE EXPLANTATION REPORT FORM. OTHER DAMAGES FOUND ARE RELATED TO THE EXPLANTATION SURGERY. THIS IS A COMBINED INITIAL/FINAL REPORT.

    Description of Event or Problem · 1

    THE USER REPORTED PAIN IN THE IMPLANT AREA AND HEARING NOISE SOMETIMES. THIS SENSATION WAS INDEPENDENT OF WHETHER THE PROCESSOR WAS WORN. THE EXPLANTATION SURGERY TOOK PLACE ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213253 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT 09008737062682

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention