BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 7701622 · Received July 19, 2018

    Report

    Report Number
    9710014-2018-00512
    Event Type
    Injury
    Date Received
    July 19, 2018
    Report Date
    August 4, 2020
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737062675
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: AS PER INFORMATION FROM THE FIELD RECIPIENT REPORTED NOISE 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. OTHER DAMAGES FOUND ARE RELATED TO THE EXPLANTATION SURGERY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    THE USER HAS NOT USED THE PROCESSOR IN A YEAR DUE TO UNBEARABLE NOISE. THE USER WAS RE-IMPLANTED ON (B)(6) 2018.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN EXPLANTED AND SHOULD 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 USER HAS NOT USED THE PROCESSOR IN A YEAR DUE TO UNBEARABLE NOISE. THE USER WAS REIMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547083 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1000 MED-EL CONCERT PIN 09008737062675

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention