BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRONY

    MDR report key: 22738861 · Received August 7, 2025

    Report

    Report Number
    9710014-2025-00724
    Event Type
    Malfunction
    Date Received
    August 7, 2025
    Date of Event
    January 31, 2025
    Report Date
    November 3, 2025
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737395353
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    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

    ADDITIONAL INFORMATION: REPORTEDLY, THE RECIPIENT EXPERIENCED RETENTION ISSUES WITH RONDO 3 MAGNET STRENGTH #5S. IT IS ASSUMED THAT THE LACK OF RETENTION MAY BE THE RESULT OF AN UNFAVORABLE COMBINATION OF DIFFERENT CIRCUMSTANCES INCLUDING PHYSIOLOGY AND ACTIVITY PROFILE OF THE RESPECTIVE USER AS WELL AS THE OWN WEIGHT OF THE RONDO 3 PROCESSOR. HENCE, THE CURRENTLY STRONGEST AVAILABLE RONDO 3 MAGNET MIGHT NOT BE SUFFICIENT. WITH THE USE OF A SONNET 3 SYSTEM, NO MORE RETENTION ISSUES WERE OBSERVED. HOWEVER, THE RECIPIENT PREFERS TO USE THE RONDO 3.

    Description of Event or Problem · 0

    THE USER WAS IMPLANTED ON (B)(6) 2024. MAGNET RETENTION FORCE IS INSUFFICIENT DESPITE SKIN FLAP <5MM, S-VECTOR INTERNAL MAGNET AND 5S RONDO3 EXTERNAL MAGNET. THE PROBLEM REMAINS SINCE ACTIVATION. RELATIVE ORIENTATION OF INTERNAL AND EXTERNAL MAGNET HAS BEEN VERIFIED - MAGNET POLES ARE ALIGNED. INTERNAL MAGNET IS ALSO ROTATABLE. DIFFERENT EXTERNAL MAGNETS HAVE BEEN TESTED. THE USER WAS IMPLANTED ON (B)(6) 2024. MAGNET RETENTION FORCE IS INSUFFICIENT DESPITE SKIN FLAP <5MM, S-VECTOR INTERNAL MAGNET AND 5S RONDO3 EXTERNAL MAGNET. THE PROBLEM REMAINS SINCE ACTIVATION. RELATIVE ORIENTATION OF INTERNAL AND EXTERNAL MAGNET HAS BEEN VERIFIED - MAGNET POLES ARE ALIGNED. INTERNAL MAGNET IS ALSO ROTATABLE. DIFFERENT EXTERNAL MAGNETS HAVE BEEN TESTED.

    Description of Event or Problem · 0

    MAGNET RETENTION FORCE IS INSUFFICIENT DESPITE SKIN FLAP <5MM, S-VECTOR INTERNAL MAGNET AND 5S RONDO3 EXTERNAL MAGNET. THE PROBLEM REMAINS SINCE ACTIVATION. DIFFERENT EXTERNAL MAGNETS HAVE BEEN TESTED. DL COIL WAS TRIED AND HOLDS WELL, BUT ALSO RELATIVELY WEAK. CURRENTLY THE USER IS TRYING A SONNET 3, IN THE HOPES TO CONVINCE THE USER OF A BTE, TO AVOID A MAGNET EXCHANGE. THE USER IS STILL USING RONDO AND REFUSES TO CHANGE TO SONNET. THE CLINIC CONSIDERS A SURGICAL EXCHANGE OF THE INTERNAL MAGNET DESPITE INTERNAL RECOMMENDATION TO GO FOR BTE AS A PRIMARY MEASURE. HOWEVER, NO FURTHER INFORMATION WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2218893 SYNCHRONY COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1250 SYNCHRONY 2 09008737395353

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention