BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2353537 · Received November 30, 2011

    Report

    Report Number
    6000034-2011-01203
    Event Type
    Malfunction
    Date Received
    November 30, 2011
    Date of Event
    November 15, 2011
    Report Date
    January 6, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    CORRECTION: THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER ON JANUARY 13, 2012, AS PREVIOUSLY REPORTED. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AS OF THE DATE OF THIS REPORT, JULY 25, 2013.THIS DEVICE IS NOT AVAILABLE FOR ANALYSIS.THIS REPORT IS FILED JULY 25, 2013. DEVICE NOT AVAILABLE FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    PER PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2011. THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE DURING THE SAME SURGERY. THIS REPORT IS FILED (B)(4) 2012.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT EXPERIENCED A LOSS OF CONNECTION TO THE INTERNAL DEVICE, AND THE ISSUE COULD NOT BE RESOLVED. THE IMPLANTED DEVICE REMAINS.THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE, HOWEVER IT IS UNKNOWN IF THIS HAS OCCURRED AS OF THE DATE OF THIS REPORT, (B)(6), 2011.

    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 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention