BEUDAMED
    FDA Adverse Event Other Summary report: N

    NUCLEUS #5

    MDR report key: 3983604 · Received August 1, 2014

    Report

    Report Number
    MW5037627
    Event Type
    Other
    Date Received
    August 1, 2014
    Date of Event
    January 1, 2011
    Report Date
    August 1, 2014
    Manufacturer
    COCHLEAR AMERICAS, INC.
    Product Code
    MCM
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTS IN 2011 SHE UNDERWENT A COCHLEAR IMPLANT PROCEDURE IN HER RIGHT EAR. SHE STATES THAT STARTING A YEAR AGO SHE HAS BEEN EXPERIENCING DAILY SHOCKS IN HER EAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451987 NUCLEUS #5 COCHLEAR IMPLANT MCM COCHLEAR AMERICAS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR