BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM.

    MDR report key: 3931873 · Received July 14, 2014

    Report

    Report Number
    6000034-2014-00978
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 17, 2014
    Report Date
    September 26, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    840024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS CURRENTLY UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED OCTOBER 7TH, 2014.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT WITH DEVICE USE. THE DEVICE WAS EXPLANTED (B)(6), 2014, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410831 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM. MCM MCM COCHLEAR LTD. CI22M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention