BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHRONY

    MDR report key: 21303168 · Received February 4, 2025

    Report

    Report Number
    9710014-2025-00104
    Event Type
    Injury
    Date Received
    February 4, 2025
    Date of Event
    January 15, 2025
    Report Date
    August 13, 2025
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    UDI-DI
    09008737094041
    PMA / PMN Number
    P000025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TC
    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

    CONCLUSION: DEVICE INVESTIGATION DID NOT REVEAL ANY DEVICE DEFECT OR DAMAGE, WHICH HAS BEEN PRESENT WHILST IMPLANTED. MECHANICAL DAMAGES FOUND DURING INVESTIGATION ARE ATTRIBUTABLE TO THE REMOVAL SURGERY. ACCORDING TO THE INFORMATION RECEIVED FROM THE FIELD THE DEVICE WAS EXPLANTED DUE TO INFECTION AND EXTRUSION OF THE DEVICE THROUGH THE SKIN. REVIEW OF THE DEVICE_S STERILIZATION RECORDS SHOW THAT THE DEVICE HAS BEEN SUBJECT TO A VALID STERILIZATION PROCESS, THUS NO AVAILABLE INFORMATION POINTS TO THE IMPLANT BEING THE SOURCE OF THE REPORTED ISSUE. HOWEVER, THE PRESENCE OF THE DEVICE MIGHT HAVE CONTRIBUTED TO ITS SUBSEQUENT DEVELOPMENT. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    THE USER INITIALLY EXPERIENCED PAIN AT THE IMPLANT SITE, PROMPTING THE SURGEON TO ADVISE DISCONTINUATION OF WEARING THE DEVICE. AFTER THREE DAYS OF NON-USAGE, THE PAIN SUBSIDED, ALLOWING THE USER TO RESUME USING THE BEHIND-THE-EAR (BTE) AUDIO PROCESSOR. HOWEVER, A FEW DAYS LATER, THE DEVICE EXTRUDED THROUGH THE SKIN. THE USER WAS EXPLANTED.

    Description of Event or Problem · 0

    THE USER INITIALLY EXPERIENCED PAIN AT THE IMPLANT SITE, PROMPTING THE SURGEON TO ADVISE DISCONTINUATION OF WEARING THE DEVICE. AFTER THREE DAYS OF NON-USAGE, THE PAIN SUBSIDED, ALLOWING THE USER TO RESUME USING THE BEHIND-THE-EAR (BTE) AUDIO PROCESSOR. HOWEVER, A FEW DAYS LATER, THE DEVICE EXTRUDED THROUGH THE SKIN. THE USER WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245839 SYNCHRONY COCHLEAR IMPLANT MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MI1200 SYNCHRONY 09008737094041

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Female Required Intervention