BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONATA

    MDR report key: 20178565 · Received September 10, 2024

    Report

    Report Number
    9710014-2024-00827
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    September 4, 2024
    Report Date
    April 14, 2025
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737042103
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ACCORDING TO THE INFORMATION RECEIVED FROM THE FIELD A TECHNICAL IMPLANT FAILURE SEEMS LIKELY. HOWEVER TO DETERMINE AN EXACT ROOT CAUSE DEVICE INVESTIGATION OF THE EXPLANTED DEVICE WOULD BE NECESSARY. THE CONCERNED DEVICE WAS EXPLANTED BUT HAS NOT BEEN RECEIVED FOR INVESTIGATION YET.

    Additional Manufacturer Narrative · 0

    CONCLUSION: DEVICE INVESTIGATION REVEALED THE SUBSTRATE OF THE DEVICE'S CIRCUITRY TO BE BROKEN. THE INVESTIGATION RESULTS APPEAR TO MATCH THE PROBLEMS MENTIONED IN THE RECIPIENT REPORT. THE EXACT REASON WHY THE CRACK OCCURRED CANNOT BE DETERMINED, HOWEVER A REVIEW OF THE DHR HAS BEEN PERFORMED AND NO ABNORMALITY WAS REVEALED, THUS THE DEVICE WAS RELEASED ACCORDING TO SPECIFICATIONS. OTHER MECHANICAL DAMAGES FOUND ARE ATTRIBUTABLE TO THE REMOVAL SURGERY. THIS IS A FINAL REPORT.

    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.

    Description of Event or Problem · 0

    THE PARENT REPORTED THAT THE RECIPIENT WAS SUDDENLY UNABLE TO HEAR SOUNDS WITH THE DEVICE SINCE MID (B)(6) 2024. THE RECIPIENT HAS BEEN RE-IMPLANTED.

    Description of Event or Problem · 0

    THE PARENT REPORTED THAT THE RECIPIENT WAS SUDDENLY UNABLE TO HEAR SOUNDS WITH THE DEVICE SINCE MID (B)(6) 2024. THE RECIPIENT HAS BEEN RE-IMPLANTED.

    Description of Event or Problem · 0

    THE PARENT REPORTED THAT THE RECIPIENT WAS SUDDENLY UNABLE TO HEAR SOUNDS WITH THE DEVICE SINCE MID AUGUST 2024. THE RECIPIENT HAS BEEN RE-IMPLANTED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223417 SONATA COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA 09008737042103

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Required Intervention