BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2981751 · Received February 27, 2013

    Report

    Report Number
    6000034-2013-00310
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    August 2, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER THE CLINIC, THE SOUND PROCESSOR WAS FOUND TO HAVE BECOME HOT (DATE NOT REPORTED). THE PROCESSOR WAS REMOVED FROM SERVICE, AND A REPLACEMENT WAS SENT. THERE WERE NO REPORTS OF PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED AS OF THE DATE OF THIS REPORT, (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83767 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R