BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 6192515 · Received December 21, 2016

    Report

    Report Number
    9710014-2016-00882
    Event Type
    Injury
    Date Received
    December 21, 2016
    Report Date
    May 2, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE INVESTIGATION CONFIRMED THAT THE STIMULATOR ELECTRONICS IS WORKING ACCORDING TO SPECIFICATIONS. HOWEVER, DURING INVESTIGATION A REDUCED ELECTRICAL IMPEDANCE BETWEEN COIL AND EAP/RG (EVOKED ACTION POTENTIALS/ REMOTE GROUND) ELECTRODE WAS DISCOVERED WHICH CAUSED THE REPORTED FAULTY EAP MEASUREMENT RESULTS. THE REASON FOR THE REPORTED NON-ACCEPTANCE OF THE AP IS UNCLEAR, AS PATIENT ACCEPTANCE OF AUDIO PROCESSOR FOR NEW DEVICE IS SIMILAR. HOWEVER A CONTRIBUTION OF THE LOWER-OHMIC CONNECTION BETWEEN COIL AND REFERENCE ELECTRODE CANNOT BE EXCLUDED. THE INVESTIGATION RESULTS APPEAR TO MATCH THE SYMPTOMS MENTIONED IN THE PATIENT REPORT. 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

    THE PATIENT DOES NOT ACCEPT THE PROCESSOR ON THE RIGHT EAR. THE PATIENT HAS BEEN RE-IMPLANTED ON (B)(6) 2016.

    Description of Event or Problem · 1

    THE PATIENT DOES NOT ACCEPT THE PROCESSOR ON THE RIGHT EAR. THE PATIENT HAS BEEN RE-IMPLANTED ON (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842489 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT PIN

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention