BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1081714 · Received July 25, 2008

    Report

    Report Number
    6000034-2008-00413
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 1, 2007
    Report Date
    June 24, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    840024
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS TYPE OF EVENT IS ADDRESSED IN THE DEVICE LABELING.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PT REPORTED THAT IN 2007, HE BEGAN TO EXPERIENCE UNINTENTIONAL EYE SQUINTING WHICH WOULD ONLY STOP WHEN THE SOUND PROCESSOR WAS REMOVED. HE ALSO REPORTED PAIN IN THE AREA OF THE RECEIVER/STIMULATOR AND THAT HE DID NOT HEAR WITH THE DEVICE. THE PT DISCONTINUED USE OF THE COCHLEAR IMPLANT SYSTEM. THE PT'S DEVICE WAS EXPLANTED IN 2008. THE PT WAS NOT REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY, DUE TO DIFFICULTY PLACING A NEW DEVICE TYPE INTO THE PREVIOUS BONE BED. THE PT IS SCHEDULED (DATE NOT REPORTED) TO BE REIMPLANTED IN THE CONTRALATERAL EAR AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM COCHLEAR LTD. CI22M NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention