BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 2882105 · Received December 18, 2012

    Report

    Report Number
    9710014-2012-00457
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    November 27, 2012
    Report Date
    December 11, 2012
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
    Product Code
    MCM
    PMA / PMN Number
    P000025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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

    IT WAS REPORTED THAT THE PT, IMPLANTED ON (B)(6) 1999, ARRIVED ON (B)(6) 2012 WITHOUT WEARING THE AUDIO PROCESSOR. IN LATE (B)(6) 2012, SHE PUT ON HER AUDIO PROCESSOR AND COULD NOT HEAR ANYTHING BUT AN ERRATIC, STATIC SOUND. THE EXTERNAL EQUIPMENT WAS EXCHANGED, BUT THIS DID NOT RESULT IN ANY IMPROVEMENT. SHE DESCRIBED THAT SHE IS NOW HEARING A CONSTANT HIGH PITCHED RINGING AND BUSSING WITHOUT THE PROCESSOR ON, AND NO SOUND WITH THE PROCESSOR ON. TESTING IN SITU SHOWS THAT THE DEVICE HAS MALFUNCTIONED. RE-IMPLANTATION SURGERY IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM C40+ H STANDARD MCM MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR