BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 1881188 · Received October 5, 2010

    Report

    Report Number
    9710014-2010-00321
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 4, 2010
    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 WHILE AT WORK THE PT WAS HIT ON THE HEAD AT THE IMPLANT SITE BY A DOOR OF A DOG KENNEL AND HE IMMEDIATELY LOST ACCESS TO SOUND. HE ATTEMPTED TO PUT ON HIS BACK-UP SPEECH PROCESSOR, BUT STILL COULD NOT HEAR. UPON SEEING HIS AUDIOLOGIST A FEW HOURS LATER, TESTING INDICATED THAT THE DEVICE HAS MALFUNCTIONED. THE AUDIOLOGIST STATED THAT THERE WAS REDNESS AND SOME SWILLING NEAR THE IMPLANT SITE. THE PT REPORTS NO PAIN OR ADVERSE REACTION DURING THE INCIDENT OR WHILE SEEING THE AUDIOLOGIST.

    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 23 YR