BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2921113 · Received January 17, 2013

    Report

    Report Number
    6000034-2013-00133
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 10, 2012
    Report Date
    February 12, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE SURGEON, THE DECISION TO EXPLANT WAS MADE BECAUSE THE PATIENT EXPERIENCED HEADACHES AND RECEIVED NO BENEFIT WITH DEVICE USE. THERE ARE NO PLANS TO REIMPLANT THAT PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT, JULY 10, 2013. THIS REPORT IS FILED ON JULY 10, 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2012. THE REASONS FOR EXPLANTATION WERE NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(62013. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AS OF THE DATE OF THIS REPORT, (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26056 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM PRODUCT CODE: MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Required Intervention