BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3041579 · Received April 8, 2013

    Report

    Report Number
    6000034-2013-00635
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 27, 2013
    Report Date
    May 22, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, AN INTEGRITY TEST REVEALED ON THAT THE DEVICE WAS FUNCTIONING PER MANUFACTURER'S EXPECTATIONS PER THE CLINIC. THE PATIENT HAS DISCONTINUED USE OF THE DEVICE (DATE NOT REPORTED).THIS REPORT IS FILED ON JULY 11, 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT REFUSED DEVICE USE. THE PATIENT WAS PUT UNDER SEDATION ON (B)(6) 2013, TO FACILITATE AN ANALYSIS OF THE INTERNAL DEVICE USING THE INTEGRITY TEST SYSTEM. THE RESULTS OF THE TEST HAVE NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4) 2013. THE IMPLANTED DEVICE REMAINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143071 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Required Intervention