BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1050191 · Received May 23, 2008

    Report

    Report Number
    6000034-2008-00277
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 18, 2008
    Report Date
    May 23, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    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 HAD AN INFECTION WITH HEADACHES, VOMITING AND UNSTEADINESS. MENINGITIS WAS RULED OUT (DATE NOT REPORTED). HE WAS TREATED WITH ANTIBIOTICS FOR APPROXIMATELY TEN DAYS. IN 2008, THE PATIENT WAS SEEN AT THE CLINIC. THERE WAS NO INDICATION OF MIDDLE EAR DYSFUNCTION OR REPORTED SYMPTOMS BUT THE PATIENT REPORTED NOT HEARING WITH THE COCHLEAR IMPLANT SYSTEM. EXCHANGING EXTERNAL EQUIPMENT DID NOT ALLEVIATE THE PROBLEM. RESULTS OF AN INTEGRITY TEST DONE ON SIX DAYS LATER WAS CONSISTENT WITH NORMAL DEVICE FUNCTION. AN X-RAY SHOWED THE COCHLEAR DEVICE TO BE IN PLACE. A TWO WEEK COURSE OF STEROIDS HAD BEEN PRESCRIBED BY THE SURGEON. REIMPLANTATION OR IMPLANTATION OF THE CONTRALATERAL EAR IS PLANNED IF THERE IS NO CHANGES IN THE PATIENT'S CONDITION. NO DECISION HAD BEEN REPORTED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM COCHLEAR IMPLANT MCM COCHLEAR LTD. CI24R(CA) NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention