BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    MDR report key: 16793840 · Received April 24, 2023

    Report

    Report Number
    9710014-2023-00340
    Event Type
    Malfunction
    Date Received
    April 24, 2023
    Date of Event
    March 6, 2023
    Report Date
    June 19, 2023
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737395452
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. NOTE: THE AGE OF THE RECIPIENT IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ACCORDING TO THE INFORMATION RECEIVED FROM THE FIELD THE RECIPIENT UNDERWENT A RE-POSITIONING SURGERY OF THE IMPLANT HOUSING BECAUSE IT WAS TOO CLOSE TO THE AUDIO PROCESSOR. THE RE-POSITIONING WAS SUCCESSFULLY PERFORMED. THE DEVICE REMAINS IMPLANTED AND IN USE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    THE USER IS UNABLE TO WEAR THE BTE PROCESSOR DUE TO ITS CLOSE PROXIMITY TO THE RECEIVER/STIMULATOR. THEREFORE, IT IS PLANNED TO MOVE THE RECEIVER MORE POSTERIORLY AND SUPERIORLY. IT IS UNCLEAR IF THE STIMULATOR HAS MOVED FROM THE INITIAL PLACEMENT. THE SURGERY FOR RE-POSITIONING IS SCHEDULED FOR (B)(6) 2023.

    Description of Event or Problem · 0

    THE USER IS UNABLE TO WEAR THE BTE PROCESSOR DUE TO ITS CLOSE PROXIMITY TO THE RECEIVER/STIMULATOR. THEREFORE, IT IS PLANNED TO MOVE THE RECEIVER MORE POSTERIORLY AND SUPERIORLY. IT IS UNCLEAR IF THE STIMULATOR HAS MOVED FROM THE INITIAL PLACEMENT. THE SURGERY FOR RE-POSITIONING TOOK PLACE ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522744 MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1250 SYNCHRONY 2 09008737395452

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention