BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 682502 · Received March 7, 2006

    Report

    Report Number
    6000034-2006-00086
    Event Type
    Injury
    Date Received
    March 7, 2006
    Date of Event
    May 11, 2005
    Report Date
    March 7, 2006
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THIS PT EXPERIENCED DIZZINESS AND WAS NOT HEARING WHEN HE ARRIVED AT THE CENTER FOR PROGRAMMING IN 5/2005 (15 YEARS POST-IMPLANTATION). THE AUDIOLOGIST EXCHANGED THE EXTERNAL EQUIPMENT, BUT THIS DID NOT RESOLVE THE HEARING DEFICIT. INTEGRITY TESTING PERFORMED IN 2005 REVEALED NORMAL RECEIVER STIMULATOR FUNCTION. HOWEVER, SEVERAL ELECTRODES WERE NOTED TO BE NOT WORKING WITHIN SPECIFICATIONS OR WERE QUESTIONABLE. BASED ON THIS PT'S POOR PERFORMANCE, THE CLINIC DECLINED TO EXPLANT THE PT IN 2006. THE PHYSICIAN REIMPLANTED THE PT WITH A NEW DEVICE SUCCESSFULLY DURING THE SAME SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention