BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1182322 · Received September 30, 2008

    Report

    Report Number
    9710014-2008-00315
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 20, 2008
    Report Date
    September 23, 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 HUSBAND CALLED THE ON-CALL AUDIOLOGIST ON BEHALF OF HIS WIFE. HIS WIFE REPORTS THAT SHE IS UNABLE TO HEAR WITH HER TEMPO+ SPEECH PROCESSOR. THEY HAVE TRIED ALL THE BACK-UP EQUIPMENT THEY HAVE AVAILABLE, BUT SHE IS STILL UNABLE TO HEAR. SHE REPORTS A CLICKING SOUND WHEN THE PROCESSOR IS TURNED ON, BUT NO OTHER SOUND. THE SPEECH PROCESSOR TEST DEVICE DOES LIGHT UP AND FLASH TO SPEECH INPUT. THE CABLE, COIL, BATTERIES AND BATTERY PACK HAVE ALL BEEN CHANGED PER PATIENT REPORT. HOWEVER, THEY DO NOT HAVE A SPARE CPU. THEY WERE ADVISED TO CALL THEIR AUDIOLOGIST FOR FURTHER TROUBLESHOOTING OF THE EQUIPMENT IN 2008. THE PATIENT ARRIVED AT THE CLINIC ON THE SAME DAY, REPORTING LOSS OF SOUND. AN EXCHANGE OF ALL EXTERNAL EQUIPMENT FAILED TO PROVIDE ANY STIMULATION TO THE PATIENT OTHER THAN THE PATIENT REPORTING A CLICK DURING THE FIRST ATTEMPTS, THEN NOTHING. TESTING WAS CARRIED OUT WHICH CONFIRMED THAT THE DEVICE HAS MALFUNCTIONED.

    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 45 YR