BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1172527 · Received September 23, 2008

    Report

    Report Number
    9710014-2008-00306
    Event Type
    Malfunction
    Date Received
    September 23, 2008
    Date of Event
    September 13, 2008
    Report Date
    September 16, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    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 PATIENT'S AUDIOLOGIST CONTACTED MED-EL CORP, STATING THAT THE PATIENT EXPERIENCED A 'POP' SOUND AND THEN LOSS OF SOUND ON SATURDAY, WHILE WATCHING TV. THE PATIENT ARRIVED AT THE CLINIC AT ABOUT TWO DAYS LATER, AND THE AUDIOLOGIST WAS UNABLE TO OBTAIN A LINK WITH THE IMPLANT USING THE DIB COIL. THE PATIENT DID REPORT A 'TAPPING' SENSATION WHEN THE DIB COIL WAS PUT INTO POSITION. A TOTAL EXCHANGE OF THE EXTERNAL EQUIPMENT FAILED TO PROVIDE ANY IMPROVEMENT. THE PATIENT DID REPORT THE SAME 'TAPPING' SENSATION WHEN BOTH HIS OWN AND THE REPLACEMENT PROCESSOR WERE PUT INTO POSITION ON HIS HEAD. THERE WERE NO OTHER REPORTS OF SOUND VIA THE IMPLANT SINCE THE 'POP' THE PATIENT REPORTED AS OCCURRING ON SATURDAY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR