BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SONATA

    MDR report key: 20308817 · Received September 26, 2024

    Report

    Report Number
    9710014-2024-00874
    Event Type
    Injury
    Date Received
    September 26, 2024
    Date of Event
    May 21, 2024
    Report Date
    November 20, 2024
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    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.

    Additional Manufacturer Narrative · 0

    CONCLUSION: ACCORDING TO THE INFORMATION RECEIVED FROM THE FIELD THE DEVICE WAS EXPLANTED DUE TO AN EXTRUSION OF THE ELECTRODE INTO THE EXTERNAL EAR CANAL. IN ADDITION, DAMAGE TO THE ACTIVE ELECTRODE, LIKELY CAUSED BY MINUTE DEVICE MOBILITY, WAS FOUND. OTHER MECHANICAL DAMAGES FOUND DURING INVESTIGATION ARE ATTRIBUTABLE TO THE REMOVAL SURGERY. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    THE RECIPIENT WAS RE-IMPLANTED DUE TO A DEHISCENCE OF THE POSTERIOR EXTERNAL AUDITORY CANAL (EAC) WALL WITH ELECTRODE ARRAY EXPOSURE.

    Description of Event or Problem · 0

    THE RECIPIENT WAS RE-IMPLANTED DUE TO A DEHISCENCE OF THE POSTERIOR EXTERNAL AUDITORY CANAL (EAC) WALL WITH ELECTRODE ARRAY EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2264419 SONATA COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Required Intervention