BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2942809 · Received February 4, 2013

    Report

    Report Number
    6000034-2013-00217
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 24, 2013
    Report Date
    November 19, 2013
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION OF THE SURGICAL INCISION WOUND. THIS REPORT IS FILED NOVEMBER 22, 2013.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Additional Manufacturer Narrative · 1

    PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2013. IT IS UNKNOWN IF THERE ARE PLANS TO REIMPLANT THE PATIENT WITH A NEW DEVICE AS OF THE DATE OF THIS REPORT. THIS REPORT IS FILED OCTOBER 29, 2013.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT UNDERWENT A REVISION SURGERY (DATE NOT REPORTED), DUE TO WOUND HEALING PROBLEMS AFTER THE INITIAL SURGERY; HOWEVER, THE ISSUE COULD NOT BE RESOLVED. CLINICAL INVESTIGATION IS ONGOING. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46657 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24R (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 26 MO Required Intervention