BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2991916 · Received March 6, 2013

    Report

    Report Number
    6000034-2013-00448
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    March 1, 2013
    Report Date
    August 1, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FILED (B)(4) 2013. DEVICE NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE RECHARGEABLE BATTERY FOR THE SOUND PROCESSOR WAS FOUND TO HAVE SWOLLEN. THE EQUIPMENT WAS ADVISED TO BE REMOVED FROM SERVICE, AND A REPLACEMENT WAS SENT. NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94674 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CP800

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention