BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 5898958 · Received August 23, 2016

    Report

    Report Number
    6000034-2016-01715
    Event Type
    Malfunction
    Date Received
    August 23, 2016
    Date of Event
    June 21, 2016
    Report Date
    August 31, 2016
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    P980027
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CORRECT PMA NUMBER IS P980027, NOT P840024 AS PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON AUGUST 24, 2016.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A PERFORMANCE DECREMENT AND LOSS OF CLINICAL BENEFIT WITH DEVICE USE; SUBSEQUENTLY, THE DEVICE WAS EXPLANTED ON (B)(6) 2016. THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547425 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI22M N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention