BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SONATA

    MDR report key: 19728126 · Received July 12, 2024

    Report

    Report Number
    9710014-2024-00620
    Event Type
    Malfunction
    Date Received
    July 12, 2024
    Date of Event
    July 9, 2024
    Report Date
    August 1, 2024
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    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

    ACCORDING TO THE CURRENTLY AVAILABLE INFORMATION, DAMAGE TO THE ACTIVE ELECTRODE LIKELY CAUSED BY MINUTE DEVICE MOBILITY IS SUSPECTED. HOWEVER, TO DETERMINE AN EXACT ROOT CAUSE A DEVICE INVESTIGATION OF THE EXPLANTED DEVICE IS NECESSARY. REPORTEDLY, THE RECIPIENT STILL HAS SOME HEARING BENEFIT WITH THE DEVICE AND WILL BE SEEN AGAIN IN (B)(6) 2024 FOR MONITORING.

    Description of Event or Problem · 0

    THE RECIPIENT VISITED THE CLINIC FOR A REVIEW MAPPING, WERE AFFECTED CHANNELS WERE SEEN. CURRENTLY OBSERVATION MILD REDNESS CAN BE SCENE NEAR THE ELECTRODE ARRAY REGION. IN ADDITION, THE MOTHER REPORTED THAT 6 MONTHS BACK THE CHILD FELL FROM BED WHICH EVEN CAUSED MINIMAL BLEEDING, PAIN, SWELLING AT THE IMPLANTED SITE. AN X-RAY HAS BEEN SUGGESTED.

    Description of Event or Problem · 0

    THE RECIPIENT VISITED THE CLINIC FOR A REVIEW MAPPING, WERE AFFECTED CHANNELS WERE SEEN. AT THE TIME OF OBSERVATION THERE WAS MILD REDNESS NEAR THE ELECTRODE ARRAY REGION. IN ADDITION, THE MOTHER REPORTED THAT 6 MONTHS BACK THE CHILD FELL FROM BED WHICH EVEN CAUSED MINIMAL BLEEDING, PAIN, SWELLING AT THE IMPLANTED SITE. AN X-RAY HAS BEEN SUGGESTED, HOWEVER, THE PARENTS DENIED SAYING THEY CANNOT PURSUE WITH ANY MEDICAL INVESTIGATIONS CURRENTLY. PROPOSED FOLLOW-UP IN 3 - 4 MONTHS. THE PARENTS BELIEVE THAT THE CHILD IS DOING PERFECTLY FINE AND HE'S HEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273226 SONATA COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SONATA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Male