BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM FOR ADULTS

    MDR report key: 194450 · Received January 31, 1997

    Report

    Report Number
    1721493-1997-00006
    Event Type
    Injury
    Date Received
    January 31, 1997
    Date of Event
    December 20, 1996
    Report Date
    January 10, 1997
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE HEALTH CARE PROFESSIONAL REPORTED THAT THE PT WAS SEEN BY THE SURGEON ON 12/20/1996. AT THAT TIME THE RECEIVER/STIMULATOR HAD BEGUN TO EXTRUDE. THE PT WAS EXPLANTED. DUE TO THE PT'S OTHER MEDICAL PROBLEMS (KIDNEY FAILURE) IT HAS NOT BEEN DECIDED WHETHER HE WILL BE REIMPLANTED. THE HEALTH CARE PROFESSIONAL HAS BEEN INFORMED THAT THE EXPLANTED DEVICE SHOULD BE RETURNED TO COCHLEAR CORPORATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention