BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 19211269 · Received April 30, 2024

    Report

    Report Number
    9710014-2024-00374
    Event Type
    Malfunction
    Date Received
    April 30, 2024
    Date of Event
    April 16, 2024
    Report Date
    August 26, 2024
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION: DEVICE INVESTIGATIONS ON THE RECEIVED PARTS DID NOT REVEAL ANY DEVICE DEFECT WHICH IS EXPECTED TO HAVE BEEN PRESENT WHILST IMPLANTED. AS PER INFORMATION FROM THE FIELD, THE DEVICE WAS NOT WORKING WITHIN SPECIFICATION, BUT DUE TO THE INCOMPLETE RECEIVED STATUS THE ROOT CAUSE COULD NOT BE DETECTED. DESPITE SEVERAL TIMES OF REQUESTING NO INFORMATION REGARDING THE CIRCUMSTANCES WHICH LED TO DEVICE EXPLANTATION HAVE BEEN RECEIVED. THIS IS A FINAL REPORT.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ACCORDING TO THE LIMITED INFORMATION RECEIVED FROM THE FIELD THE RECIPIENT NO LONGER HAS HEARING BENEFIT WITH THE DEVICE AND DEVICE DEFECT WAS REPORTED. HOWEVER, DESPITE REQUESTED NEITHER RESULTS OF IN SITU TESTING NOR THE DEVICE HAS BEEN RECEIVED FOR INVESTIGATION. FURTHER, THERE IS NO INFORMATION ON THE PLACEMENT OF THE FLOATING MASS TRANSDUCER. A ROOT CAUSE FOR THE LACK OF BENEFIT CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN EXPLANTED AND 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

    HEARING PERFORMANCE WITH THE DEVICE WAS REPORTEDLY AFFECTED. IN SITU TESTING WAS INDICATIVE OF A DEFECTIVE DEVICE. THE USER HAS BEEN RE-IMPLANTED.

    Description of Event or Problem · 0

    HEARING PERFORMANCE WITH THE DEVICE WAS REPORTEDLY AFFECTED. INFORMATION WAS RECEIVED THAT THE DEVICE WAS FOUND TO BE DEFECTIVE. THE USER HAS BEEN RE-IMPLANTED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED THAT THE DEVICE WAS FOUND TO BE DEFECTIVE. THE DEVICE HAS BEEN EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130836 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MPV MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH VORP

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female Required Intervention