BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2101499 · Received May 17, 2011

    Report

    Report Number
    3006556115-2011-00270
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    March 26, 1998
    Report Date
    April 26, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. THE PATIENT'S DEVICE WAS IMPLANTED. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    IT WAS RECENTLY REPORTED THAT THE PATIENT REPORTEDLY EXPERIENCED A CSF LEAK DURING INITIAL IMPLANTATION. THE CSF LEAK REQUIRED A PATCH. THE PATIENT WAS SUCCESSFULLY IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention