BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRONY

    MDR report key: 20504523 · Received October 22, 2024

    Report

    Report Number
    9710014-2024-00948
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    October 16, 2024
    Report Date
    February 10, 2025
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737331870
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: DAMAGE TO THE ACTIVE ELECTRODE WHICH IS CONSISTENT WITH MINUTE DEVICE MOBILITY WAS DETERMINED TO HAVE LED TO DEVICE FAILURE OVER TIME DUE TO FATIGUE WIRE BREAKAGES. THE PROBLEMS GIVEN IN THE RECIPIENT REPORT APPEAR TO MATCH THE DAMAGE FOUND. OTHER DAMAGES FOUND DURING DEVICE INVESTIGATION ARE MOST LIKELY RELATED TO THE EXPLANTATION SURGERY. THIS IS A FINAL REPORT.

    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.

    Description of Event or Problem · 0

    THE USER STARTED TO REPORT NOT HEARING WITH THE DEVICE AROUND (B)(6) 2024; A COUPLE OF DAYS PRIOR SHE WAS EXPERIENCING HEARING A "ZZZ" SOUND. THE USER HAS BEEN RE-IMPLANTED.

    Description of Event or Problem · 0

    THE USER STARTED TO COMPLAIN ABOUT NOT HEARING AROUND 10TH OCTOBER 2024; A COUPLE OF DAYS PRIOR SHE COMPLAINED ABOUT HEARING A "ZZZ" SOUND. RE-IMPLANTATION IS CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817068 SYNCHRONY COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1210 SYNCHRONY ST 09008737331870

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Female Required Intervention