BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3770053 · Received April 24, 2014

    Report

    Report Number
    6000034-2014-00649
    Event Type
    Injury
    Date Received
    April 24, 2014
    Report Date
    May 26, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE CURRENTLY UNAVAILABLE.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED SKIN FLAP BREAKDOWN AT THE IMPLANT SITE AND SUBSEQUENTLY THE DEVICE WAS EXPLANTED (B)(6), 2014. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT, (B)(6), 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248836 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM, PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention