BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2981768 · Received February 27, 2013

    Report

    Report Number
    6000034-2013-00312
    Event Type
    Malfunction
    Date Received
    February 27, 2013
    Report Date
    July 29, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED ON AUGUST 22, 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED EXCESSIVE BATTERY DRAIN, LEADING TO DEVICE NON-USE. THE DEVICE WAS EXPLANTED ON (B)(6) 2013, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84286 NUCLEUS 22 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI22M

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention