BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2853864 · Received December 3, 2012

    Report

    Report Number
    6000034-2012-02298
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    November 14, 2012
    Report Date
    August 6, 2013
    Manufacturer
    COCHLEAR LTD
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY GOT SWOLLEN DURING CHARGING. NO REPORTS OF PATIENT INJURY ARE ASSOCIATED WITH THIS EVENT.THE EQUIPMENT WAS ADVISED TO BE REMOVED FROM SERVICE, AND A REPLACEMENT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD CP800

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention