BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIBRANT SOUNDBRIDGE

    MDR report key: 3042283 · Received April 3, 2013

    Report

    Report Number
    3004230826-2013-00032
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    January 25, 2013
    Report Date
    July 9, 2020
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MPV
    PMA / PMN Number
    P990052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN EXPLANTED. IF IT SHOULD BE EXPLANTED, IT IS TO BE RETURNED TO THE MFR FOR EVALUATION. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. CURRENTLY AVAILABLE INFORMATION, DOES NOT ALLOW A ROOT CAUSE DETERMINATION FOR THE REPORTED NO OUTPUT CONDITION DESPITE SEVERAL INQUIRES NO FURTHER INFORMATION HAS BEEN RECEIVED. SO FAR NO DATE FOR EXPLANTATION HAS BEEN SET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, THE PT SAID THAT SHE COULD NO LONGER HEAR. PRIOR TO THIS DATE THE PT'S EAR HAD BEEN CLEANED. ON (B)(6) SHE WENT TO HER DOCTOR AND UNDERWENT A REVISION SURGERY. AFTER THIS SURGERY SHE WAS STILL NOT ABLE TO HEAR.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORT OF MARCH 25, 2013, THE PATIENT COMPLAINT ABOUT NO HEARING SENSATION ON (B)(6) 2013. PRIOR TO THIS DATE THE PATIENT'S EAR HAD BEEN CLEANED. ON (B)(6), SHE WENT TO HER DOCTOR AND UNDERWENT A REVISION SURGERY. AFTER THIS SURGERY SHE WAS STILL NOT ABLE TO HEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136317 VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT MPV MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH VORP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention