BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 17405711 · Received July 27, 2023

    Report

    Report Number
    9710014-2023-00655
    Event Type
    Malfunction
    Date Received
    July 27, 2023
    Date of Event
    August 20, 2018
    Report Date
    January 10, 2024
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737093952
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ACCORDING TO THE CURRENTLY AVAILABLE INFORMATION, DAMAGE TO THE ACTIVE ELECTRODE LIKELY CAUSED BY MINUTE DEVICE MOBILITY IS PLAUSIBLE. IN ADDITION, A COMPLETE INSERTION OF THE ELECTRODE ARRAY WAS NOT ACHIEVED AT IMPLANTATION SURGERY WITH TWO CHANNELS REMAINING EXTRA-COCHLEAR. FURTHER DIAGNOSTIC IMAGING INDICATES A FURTHER MIGRATION OF THE ELECTRODE OUT OF COCHLEA WITH CURRENTLY THREE EXTRA-COCHLEAR CHANNELS. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE A DEVICE INVESTIGATION OF THE EXPLANTED DEVICE IS NECESSARY. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ACCORDING TO THE CURRENTLY AVAILABLE INFORMATION, DAMAGE TO THE ACTIVE ELECTRODE LIKELY CAUSED BY MINUTE DEVICE MOBILITY IS PLAUSIBLE. IN ADDITION A COMPLETE INSERTION OF THE ELECTRODE ARRAY WAS NOT ACHIEVED AT IMPLANTATION SURGERY WITH TWO CHANNELS REMAINING EXTRA-COCHLEAR. FURTHER DIAGNOSTIC IMAGING INDICATES A FURTHER MIGRATION OF THE ELECTRODE OUT OF COCHLEA WITH CURRENTLY THREE EXTRA-COCHLEAR CHANNELS. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE A DEVICE INVESTIGATION OF THE EXPLANTED DEVICE IS NECESSARY. RE-IMPLANTATION WAS CARRIED OUT, BUT THE DEVICE HAS NOT BEEN RECEIVED FOR INVESTIGATION YET.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT 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 · 0

    IN SITU MEASUREMENTS SHOWED AFFECTED CHANNELS. THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED.

    Description of Event or Problem · 0

    IN SITU MEASUREMENTS SHOWED AFFECTED CHANNELS. THE USER WAS REIMPLANTED ON (B)(6) 2023.

    Description of Event or Problem · 0

    IN SITU MEASUREMENTS SHOWED AFFECTED CHANNELS. THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED. CT IMAGING WILL BE PERFORMED AND REVISION SURGERY IS CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1232416 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY 09008737093952

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Male Required Intervention