BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 19432755 · Received May 31, 2024

    Report

    Report Number
    9710014-2024-00491
    Event Type
    Malfunction
    Date Received
    May 31, 2024
    Date of Event
    May 22, 2024
    Report Date
    March 3, 2025
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    UDI-DI
    09008738515460
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ACCORDING TO THE INFORMATION RECEIVED FROM THE FIELD A TECHNICAL IMPLANT FAILURE DUE TO THE REPORTED EXTERNAL MECHANICAL IMPACT SEEMS LIKELY. HOWEVER, TO DETERMINE AN EXACT ROOT CASUE DEVICE INVESTIGATION OF THE EXPLANTED DEVICE WOULD BE NECESSARY. NO INFORMATION ON FURTHER STEPS HAS BEEN RECEIVED DESPITE REQUESTED.

    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: DAMAGE TO THE LEAD WIRE OF THE CONDUCTIVE LINK AS MIGHT BE CAUSED BY MINUTE DEVICE MOBILITY WAS DETERMINED TO BE THE ROOT CAUSE OF DEVICE FAILURE. THE OBSERVED TRAUMA MIGHT HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE PROBLEMS GIVEN IN THE RECIPIENT REPORT SEEM TO BE CONGRUENT WITH THE DAMAGE FOUND. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER AN ACCIDENT. FURTHER MEDICAL INTERVENTION IS CURRENTLY UNKNOWN AS THE USER DID NOT ATTEND THE LAST APPOINTMENT.

    Description of Event or Problem · 0

    THE USER'S HEARING PERFORMANCE WITH THE DEVICE IS AFFECTED AFTER AN ACCIDENT. THE USER WILL TRY A HEARING AID, SINCE IMPROVEMENTS IN AIR CONDUCTION HEARING WERE REPORTEDLY ACHIEVED WITH THE OPERATION OF THE VORP IMPLANT AND BELL COUPLER. THE USER WILL COME BACK TO THE CLINIC ON (B)(6) 2024 TO DISCUSS THE ISSUE FURTHER.

    Description of Event or Problem · 0

    THE USER'S HEARING PERFORMANCE WITH THE DEVICE WAS AFFECTED AFTER A TRAUMA.THE USER HAS BEEN RE-IMPLANTED WITH A NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215165 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MPV MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH VORP 503 09008738515460

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention