BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3537715 · Received December 26, 2013

    Report

    Report Number
    6000034-2013-02187
    Event Type
    Malfunction
    Date Received
    December 26, 2013
    Date of Event
    November 19, 2013
    Report Date
    March 27, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    840024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: PMA/510K NUMBER WAS PREVIOUSLY REPORTED AS 890024. THIS IS INCORRECT. THE CORRECT NUMBER IS 840024. THIS REPORT IS FILED APRIL 22, 2014.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A DECLINE IN PERFORMANCE WITH DEVICE USE; THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (B)(6) 2013; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH ANOTHER MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675714 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE MCM MCM COCHLEAR LTD. CI22M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention