BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3031687 · Received April 2, 2013

    Report

    Report Number
    6000034-2013-00579
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    April 24, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED EXTRUSION OF THE RECEIVER/STIMULATOR (DATE NOT REPORTED). ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED AS OF THE DATE OF THIS REPORT, (B)(6) 2013.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
    135002 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention