BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 3884065 · Received June 19, 2014

    Report

    Report Number
    6000034-2014-00867
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    June 27, 2014
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS CURRENTLY UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    CORRECTION: IN THE INITIAL MDR, COCHLEAR AMERICAS REPORTED THE DEVICE IN QUESTION WAS EXPLANTED AND A NEW DEVICE WAS IMPLANTED ON THE SAME DAY ((B)(6) 2014). HOWEVER, PER THE CLINIC, THE DEVICE BEARING SERIAL NUMBER (B)(4) WAS EXPLANTED FROM THE PATIENT IN (B)(6) 2013 (EXACT DATE UNKNOWN). ON (B)(6) 2014, THE PATIENT WAS RE-IMPLANTED WITH A NEW DEVICE. THE DEVICE IN QUESTION WAS EXPLANTED DUE TO A WOUND INFECTION. THIS REPORT IS FILED 31 JUL 2015. DEVICE UNAVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED ON (B)(6) 2014 DUE TO UNKNOWN REASONS. DURING THE SAME SURGERY, THE PATIENT WAS IMPLANTED WITH A NEW DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN MADE AVAILABLE AS OF THE DATE OF THIS REPORT, (B)(4) 2014. THE DEVICE HAS NOT BEEN MADE AVAILABLE FOR ANALYSIS AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360445 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24RE (CA)

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention