BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 375023 · Received February 1, 2002

    Report

    Report Number
    2029203-2002-00035
    Event Type
    Injury
    Date Received
    February 1, 2002
    Date of Event
    November 1, 1999
    Report Date
    January 31, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1999, PATIENT WAS SEEN AT IMPLANT CENTER TO EVALUATE COMPLAINT OF PAIN WHEN PLACING THE HEADPIECE. THE SURGEON NOTED THAT THE PATIENT DID NOT HAVE ANY SIGNS OF INFECTION. THE SURGEON FELT THAT A SUTURE MAY HAVE BROKEN, CAUSING THE POSTERIOR END OF THE DEVICE TO EXTRUDE. REVISION SURGERY WAS SCHEDULED TO REPOSITION THE DEVICE AND RE-SUTURE INTO PLACE. DURING THIS SURGERY, THE SURGEON FOUND IT NECESSARY TO EXPLANT DEVICE DUE TO OTHER PHYSIOLOGICAL ISSUES THAT WERE OBSERVED IN THE BONE BED DURING REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention