BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 16528056 · Received March 13, 2023

    Report

    Report Number
    9710014-2023-00214
    Event Type
    Malfunction
    Date Received
    March 13, 2023
    Date of Event
    May 15, 2022
    Report Date
    June 6, 2023
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    UDI-DI
    09008738510809
    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 THE RECIPIENT HAD NO BENEFIT AFTER AN IMPACT TO THE HEAD THAT MIGHT HAVE CONTRIBUTED TO THE OBSERVED FOOTPLATE IMMOBILISATION. A REVISION SURGERY WAS PERFORMED TO RE-POSITION THE FLOATING MASS TRANSDUCER FROM THE INCUS TO THE ROUND WINDOW. IN SITU TESTING AFTER REVISION SURGERY SHOWED A FUNCTIONING DEVICE. DESPITE AFTER REVISION AIR CONDUCTION AND BONE CONDUCTION COULD BE INTERMITTENTLY MEASURED, THE RECIPIENT DID NOT REPORT ANY HEARING IMPRESSION. FURTHER PHYSIOLOGICAL CHECKS ARE PLANNED.

    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

    UP UNTIL (B)(6) 2022 THE USER HAD GOOD SPEECH UNDERSTANDING (100% MONOSYLLABIC). THE USER THEN HAD AN ACCIDENT AND HIT THE IMPLANT SIDE ON A DOOR. IN AUGUST 2022 THE USER REPORTED NOT BEING ABLE TO HEAR ANY SOUND. PSYCHOLOGICAL INTERVENTION IS CONSIDERED. NO FURTHER INFORMATION HAS BEEN RECEIVED AS OF (B)(6)2023.

    Description of Event or Problem · 0

    UP UNTIL (B)(6) 2022 THE USER HAD GOOD SPEECH UNDERSTANDING (100% MONOSYLLABIC). THE USER THEN HAD AN ACCIDENT AND HIT THE IMPLANT SIDE ON A DOOR. IN (B)(6) 2022 THE USER REPORTED NOT BEING ABLE TO HEAR ANY SOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473694 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MPV MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH VORP 503 09008738510809

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Male Required Intervention