BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 1934737 · Received December 21, 2010

    Report

    Report Number
    6000034-2010-00812
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    December 15, 2010
    Report Date
    August 29, 2011
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS EXPLANTED ON (B)(6) 2010 DUE TO PARTIAL INSERTION; DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED. DEVICE NOT AVAILABLE FOR ANALYSIS. (B)(4). DEVICE NOT AVAILABLE FOR ANALYSIS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE DEVICE WAS EXPLANTED DUE TO UNSPECIFIED REASONS. THE MANUFACTURER BECAME AWARE UPON RECEIPT OF THE IMPLANT REGISTRATION CARD FOR THE NEWLY-IMPLANTED DEVICE ON (B)(6), 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI512 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention