BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3931036 · Received July 14, 2014

    Report

    Report Number
    6000034-2014-00971
    Event Type
    Injury
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    March 10, 2015
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FILED MAY 16, 2015.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    PER THE CLINIC, IMAGING (TYPE AND DATE NOT REPORTED) REVEALED THAT THE ELECTRODE ARRAY WAS NOT IN THE COCHLEA. THE DEVICE WAS EXPLANTED ON (B)(6) 2014 AND THE PATIENT REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    411110 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 21 MO Required Intervention