BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1182319 · Received September 30, 2008

    Report

    Report Number
    9710014-2008-00310
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 17, 2008
    Report Date
    September 18, 2008
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 FELL AND HIT HIS HEAD AT THE IMPLANTED SITE ABOUT TWO WEEKS AGO. DURING ROUTINE TESTING IN 2008, ALL ELECTRODE CHANNELS SHOWED STATUS OK. TESTING WAS CARRIED OUT AGAIN TWO MONTHS LATER, WHICH SHOWED CHANNELS 1-7, 11 AND 12 WITH STATUS HI AND TWO SHORT-CIRCUITS BETWEEN CHANNELS 6/7 AND 9/10. GROUND PATH IMPEDANCE WAS NOT MEASUREABLE. ONLY CHANNEL 8 SHOWED NORMAL RESULTS.

    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 PULSAR

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR