BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1461197 · Received September 2, 2009

    Report

    Report Number
    6000034-2009-00167
    Event Type
    Malfunction
    Date Received
    September 2, 2009
    Date of Event
    February 18, 2009
    Report Date
    March 18, 2009
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4).COCHLEAR ATTEMPTED AN ELECTRONIC SUBMISSION ON MARCH 19, 2009, UNSUCCESSFULLY. COCHLEAR SUBMITTED PAPER SUBMISSION MARCH 9, 2009 AND PER FDA REQUEST, SUBMITTING ELECTRONICALLY.

    Description of Event or Problem · 1

    PER THE AUDIOLOGIST, THE PATIENT WAS EXPERIENCING PAIN WHEN USING THE DEVICE. RESULTS OF AN INTEGRITY TEST (B) (6), 2009 INDICATE THE DEVICE IS FUNCTIONING WITHIN NORMAL SPECIFICATIONS WITH SOME ANOMALIES. REPROGRAMMING DIDN¿T ALLEVIATE THE PAIN. EXPLANT AND REIMPLANTATION IS PLANNED, BUT HAD NOT BEEN SCHEDULED AT THE TIME OF THIS REPORT, MARCH 19, 2009.

    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 21 YR Required Intervention