BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 3060076 · Received April 11, 2013

    Report

    Report Number
    3006556115-2013-00153
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 22, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A CSF LEAK DURING INITIAL IMPLANT SURGERY. THE CSF LEAK WAS REPAIRED AND THE PT WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154289 NI COCHLEAR IMPLAT MCM ADVANCED BIONICS LLC NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention