BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1760329 · Received July 16, 2010

    Report

    Report Number
    6000034-2010-00460
    Event Type
    Malfunction
    Date Received
    July 16, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 10, 2010
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRITY TEST RESULTS FROM (B)(6) 2010 PRESENTED EVIDENCE OF A DEVICE MALFUNCTION.(B)(4): DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 32 MG/DL, 62 MG/DL AND 52 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT PRESENTED AFTER 8 YEARS OF DEVICE NON-USE. IT WAS REPORTED THAT THE PATIENT WAS RECEIVING NO BENEFIT FROM THE DEVICE BEFORE THE DECISION WAS MADE TO DISCONTINUE USE. A CLINICAL EVALUATION OF THE PATIENT IS UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention