BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    MDR report key: 731160 · Received June 23, 2006

    Report

    Report Number
    9710014-2006-00165
    Event Type
    Malfunction
    Date Received
    June 23, 2006
    Date of Event
    June 17, 2006
    Report Date
    June 22, 2006
    Manufacturer
    MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 FELL OUT OF A HAMMOCK, ONTO HARD WOODEN DECKING, IMPACTING HIS IMPLANT SIDE. SUBSEQUENTLY UNRESPONSIVE TO SOUND- PREVIOUSLY HE WAS A GOOD USER. TESTING SHOWED THAT ALL ELECTRODE CHANNELS WERE HI, >16 KOMS. A DEVICE ASSESSMENT HAS BEEN ARRANGED FOR IN 2006, WITH SURGERY PROVISIONALLY SCHEDULED IN A WEEK.

    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 5 YR