BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 6255708 · Received January 17, 2017

    Report

    Report Number
    9710014-2017-00059
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Report Date
    March 30, 2017
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: BASED ON AVAILABLE INFORMATION, OBSERVED SYMPTOMS MIGHT BE CAUSED BY A DEVICE MALFUNCTION OR BY MEDICAL REASONS. HOWEVER, SINCE THE PATIENT IS REFUSING FURTHER TREATMENT NO ROOT CAUSE CAN BE IDENTIFIED AT THIS TIME. THE COMPLAINT WILL BE RE-OPENED AND FURTHER INVESTIGATED IF AND WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO 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 · 1

    THE PATIENT WAS NOT ABLE TO HEAR WITH THE DEVICE SO A LOANER AUDIO PROCESSOR (AP) WAS DELIVERED TO HIM. THE LOANER AP WAS CHECKED IN THE OFFICE PRIOR TO BEING MAILED AND WAS FOUND TO BE FUNCTIONING, HOWEVER THE PATIENT WAS STILL NOT ABLE TO HEAR WITH THE DEVICE. THE PATIENT REPORTED HIS HEARING GOT WORSE OVER TIME AND THEN AT ONE POINT HE WAS NO LONGER ABLE TO HEAR WITH THE DEVICE. THE PATIENT HAD THE IMPLANT CHECKED BY PHYSICIAN WHO REPORTED THAT THE IMPLANT IS NOT WORKING. THE PATIENT HAS CONTACTED THE AKH WIEN FOR FURTHER TROUBLESHOOTING AND TO DETERMINE IF HE IS STILL WITHIN THE INDICATION CRITERIA FOR THIS IMPLANT. THE APPOINTMENT WILL TAKE PLACE IN (B)(6) 2017. AN APPOINTMENT WAS SCHEDULED FOR (B)(6) 2017 BUT THE PATIENT DID NOT SHOW UP FOR THE APPOINTMENT. THE PATIENT WAS CONTACTED BY PHONE AND HE DID NOT GIVE A REASON FOR MISSING THE APPOINTMENT AND STATED HE WILL NOT HAVE A CHECK-UP IN THE NEAR FUTURE. AS THE PATIENT HAS NOT BEEN SEEN, IT IS NOT POSSIBLE TO FIND OUT WHETHER HE IS OUT OF CRITERIA OR IF THE IMPLANT IS STILL FUNCTIONING. THE SURGEON ALSO HAS NO FURTHER INFORMATION ABOUT THIS CASE.

    Description of Event or Problem · 1

    THE PATIENT WAS NOT ABLE TO HEAR WITH THE DEVICE SO A LOANER AUDIO PROCESSOR (AP) WAS DELIVERED TO HIM. THE LOANER AP WAS CHECKED IN THE OFFICE PRIOR TO BEING MAILED AND WAS FOUND TO BE FUNCTIONING, HOWEVER THE PATIENT WAS STILL NOT ABLE TO HEAR WITH THE DEVICE. THE PATIENT REPORTED HIS HEARING GOT WORSE OVER TIME AND THEN AT ONE POINT HE WAS NO LONGER ABLE TO HEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41147 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MPV MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH VORP

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR