BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2924314 · Received January 22, 2013

    Report

    Report Number
    6000034-2013-00146
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    September 8, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER THE CLINIC, IT WAS REPORTED THAT THE RECHARGEABLE BATTERY OF THE SOUND PROCESSOR WAS FOUND TO HAVE BECOME SWOLLEN. THERE WERE NO ALLEGATIONS OF PATIENT INJURY ASSOCIATED WITH THIS EVENT. AWAITING RETURN OF THE PRODUCT FOR INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30700 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CP800

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention