BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2863386 · Received December 10, 2012

    Report

    Report Number
    6000034-2012-02326
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 28, 2012
    Report Date
    January 22, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    FURTHER INVESTIGATION HAS BEEN COMPLETED AND RESULTS INDICATED THAT THE WHITE POWDER BELIEVED TO BE BATTERY FLUID, WAS FOUND TO BE DUST. THIS REPORT IS FILED (B)(4) 2013

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERIES APPEAR TO HAVE LEAKED. THE EQUIPMENT WAS ADVISED TO BE REMOVED FROM SERVICE, AND A REPLACEMENT WILL BE SENT. NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT. THE MANUFACTURER BECAME AWARE UPON RECEIPT OF THE BATTERIES ON (B)(4) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN PROVIDED AS OF THE DATE OF THIS REPORT, (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD SP12

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention