BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3031694 · Received April 2, 2013

    Report

    Report Number
    6000034-2013-00586
    Event Type
    Injury
    Date Received
    April 2, 2013
    Date of Event
    March 13, 2013
    Report Date
    October 8, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALL MDRS WITH MFR REPORT NUMBER 6000034-2013-00586 WERE DUPLICATES OF MDRS FILED WITH MFR REPORT NUMBER 6000034-2013-00565. THIS REPORT IS FILED 31 JAN 2014.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTION: THE CORRECT SERIAL NUMBER OF THE INVOLVED DEVICE IS (B)(4); NOT (B)(4) AS PREVIOUSLY REPORTED. (B)(4).

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED ABNORMAL SOUND QUALITY AND INTERMITTENCY WITH DEVICE USE, AND THE ISSUE COULD NOT BE RESOLVED. THE DEVICE WAS EXPLANTED (B)(6) 2013, AND THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    133733 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention