BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2870882 · Received December 12, 2012

    Report

    Report Number
    6000034-2012-02356
    Event Type
    Injury
    Date Received
    December 12, 2012
    Date of Event
    May 10, 2012
    Report Date
    July 9, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A PROCEDURE TO REPOSITION THE RECEIVER-STIMULATOR ON (B)(6) 2013. IMPLANTED DEVICE REMAINS. THIS REPORT IS FILED OCTOBER 16, 2013. IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    (B)(4) IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2012, TO CORRECT MIGRATION OF THE RECEIVER/STIMULATOR. IT WAS ALSO REPORTED THAT AS OF (B)(6) 2012, THE RECEIVER/STIMULATOR HAS AGAIN MIGRATED FROM THE CORRECT POSITIONING. THE IMPLANTED DEVICE REMAINS. THERE ARE PLANS TO REPOSITION THE RECEIVER/STIMULATOR, BUT IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(4) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI512

    Patients

    Seq Age Sex Outcome Treatment
    1 29 MO Required Intervention