BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRONY

    MDR report key: 20074646 · Received August 27, 2024

    Report

    Report Number
    9710014-2024-00773
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    August 23, 2024
    Report Date
    November 19, 2024
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737395452
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    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.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: BASED ON THE INFORMATION RECEIVED FROM THE FIELD, THE ACTIVE ELECTRODE POST-OPERATIVELY MIGRATED OUT OF THE COCHLEA. THE CONCERNED DEVICE WAS EXPLANTED BUT HAS NOT BEEN RECEIVED FOR INVESTIGATION YET.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: BASED ON THE INFORMATION RECEIVED FROM THE FIELD, THE ACTIVE ELECTRODE POST-OPERATIVELY MIGRATED OUT OF THE COCHLEA. A REVISION SURGERY IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.

    Description of Event or Problem · 0

    THE MIGRATION OF THE DEVICE WAS REPORTED. CT SCANS REVEALED 2 CHANNELS BEING OUT OF THE COCHLEA WITH CHANNEL 10 SITTING ON THE ROUND WINDOW.

    Description of Event or Problem · 0

    A MIGRATION OF THE DEVICE WAS REPORTED. THE USER WAS REIMPLANTED.

    Description of Event or Problem · 0

    A MIGRATION OF THE DEVICE WAS REPORTED. A CT SCAN REVEALED 2 CHANNELS BEING OUT OF THE COCHLEA AND 1 CHANNEL SITTING ON THE ROUND WINDOW. A REVISION SURGERY IS CONSIDERED, BUT NO DATE HAS BEEN SCHEDULED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939851 SYNCHRONY COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1250 SYNCHRONY 2 09008737395452

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Female Required Intervention