BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 14267766 · Received May 3, 2022

    Report

    Report Number
    9710014-2022-00308
    Event Type
    Malfunction
    Date Received
    May 3, 2022
    Report Date
    May 30, 2023
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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: BASED ON THE RECEIVED INFORMATION, THE RECIPIENT DOES NOT BENEFIT FROM THE DEVICE ANYMORE. IN SITU TESTING IS INDICATIVE OF A DEVICE MALFUNCTION. HOWEVER TO DETERMINE AN EXACT ROOT CAUSE FOR THE DEVICE MALFUNCTION A DEVICE INVESTIGATION ON THE EXPLANTED DEVICE WOULD BE NECESSARY. IN ADDITION THE RECIPIENT FELL OUT OF AUDIOLOGICAL CRITERIA RANGE OF VIBRANT SOUND BRIDGE OVER TIME FOR UNDETERMINED REASONS. RE-IMPLANTATION IS CONSIDERED BUT NO DATE HAS BEEN SCHEDULED YET.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: BASED ON THE INFORMATION RECEIVED, THE RECIPIENT DID NOT BENEFIT ANYMORE FROM THE VIBRANT SOUNDBRIDGE. REPORTEDLY THE RECIPIENT FELL OUT OF AUDIOLOGICAL CRITERIA RANGE OF VIBRANT SOUNDBRIDGE OVER TIME FOR UNDETERMINED REASONS. NO FURTHER STEPS ARE PLANNED AT THE MOMENT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ACCORDING TO THE INFORMATION RECEIVED FROM THE FIELD THE LACK OF BENEFIT WAS LIKELY DUE TO INSUFFICIENT COUPLING DUE TO A POST-OPERATIVE MIGRATION OF THE COUPLER. A RE-POSITIONING SURGERY WAS PERFORMED SUCCESSFULLY AND THE RECIPIENT IS SATISFIED WITH THE HEARING PERFORMANCE. IN ADDITION IN SITU MEASUREMENTS SHOWED INTERMITTENT NO FUNCTION DUE TO UNDETERMINED REASONS. THE DEVICE REMAINS IMPLANTED AND IN USE. THIS IS A FINAL REPORT.

    Description of Event or Problem · 0

    THE USER REPORTED THAT HE NO LONGER HAD ANY HEARING SENSATION WITH THE DEVICE ON THE LEFT SIDE.

    Description of Event or Problem · 0

    THE USER REPORTED THAT HE NO LONGER HAD ANY HEARING SENSATION WITH THE DEVICE ON THE LEFT SIDE. AS PER INFORMATION FROM 06.JUL.2022 THE USER IS AT THE BORDER OR OUT OF INDICATION CRITERIA AND THEREFORE DOES NOT HAVE ANY BENEFIT WITH THE DEVICE ANYMORE.RE-IMPLANTATION WITH A COCHLEAR IMPLANT WAS CONSIDERED BUT DESPITE SEVERAL REQUESTS NO CONFIRMATION ON WHETHER THIS OCCURRED HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    THE USER REPORTED THAT HE NO LONGER HAD ANY HEARING SENSATION WITH THE DEVICE ON THE LEFT SIDE. AS PER INFORMATION FROM 06.JUL.2022 THE USER IS AT THE BORDER OR OUT OF INDICATION CRITERIA AND THEREFORE DOES NOT HAVE ANY BENEFIT WITH THE DEVICE ANYMORE. CURRENTLY THERE ARE NO PLANS TO EXPLANT THE CONCERNED DEVICE.

    Description of Event or Problem · 0

    THE USER REPORTED THAT HE NO LONGER HAD ANY HEARING SENSATION WITH THE DEVICE ON THE LEFT SIDE. THE AUDIO PROCESSOR WAS CHECKED, AND NO PROBLEMS WERE DETECTED. THE USER UNDERWENT A REVISION SURGERY ON (B)(6) 2022. THE IMPLANT WAS LEFT IN PLACE AND THE COUPLER WAS RECOUPLED. THE USER WAS REPORTEDLY HAPPY DURING THE FITTING ON (B)(6) 2022. DIRECT STIMULATION OF THE DEVICE SHOWED LOW HEARING THRESHOLDS. THE USER WAS SEEN IN THE CLINIC IN (B)(6) 2023 AND IS DOING FINE. HE IS SATISFIED WITH HIS HEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1318661 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MPV MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH VORP

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Required Intervention