BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1082796 · Received July 23, 2008

    Report

    Report Number
    6000034-2008-00401
    Event Type
    Malfunction
    Date Received
    July 23, 2008
    Date of Event
    September 11, 2007
    Report Date
    June 23, 2008
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Removal / Correction Number
    NA
    Product Problem
    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 THE COCHLEAR IMPLANT SYS SUDDENLY STOPPED WORKING WHILE HE WAS DRIVING TO WORK. EXCHANGING THE EXTERNAL EQUIPMENT DID NOT ALLEVIATE THE PROBLEM. THERE WERE NO REPORTED SIGNS OF SWELLING, REDNESS, INFECTION, PAIN OR ABNORMAL HLTH SYMPTOMS DURING THIS TIME. EXPERT REVIEW OF THE RESULTS OF AN INTEGRITY TEST DONE IN 2007 SUGGESTED THE DEVICE MIGHT NOT BE WORKING WITHIN SPECS. HOWEVER, DUE TO POSSIBLE TECHNICAL DIFFICULTIES, A REPEAT INTEGRITY TEST WAS REQUESTED. THE PT'S DEVICE WAS EXPLANTED (DATE NOT REPORTED) AND A NEW DEVICE WAS REIMPLANTED DURING THE SAME SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention