BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN CERTAS INLINE VLV

    MDR report key: 3450142 · Received November 5, 2013

    Report

    Report Number
    1226348-2013-32544
    Event Type
    Injury
    Date Received
    November 5, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC MEDOS
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASSOCIATED WITH COMPLAINT NUMBER (B)(4). FOLLOW UP REPORT IS BEING FILED TO CHANGE REPORTING DECISION FROM MALFUNCTION TO SERIOUS INJURY.REP REPORTED THAT THE SURGEON WAS UNABLE TO VISUALIZE ANY MARKERS ON X-RAY, UNABLE TO DETERMINE ORIENTATION AND UNABLE TO ACCURATELY DETERMINE SETTING VIA X-RAY. SURGEON DECIDED TO X-RAY THE PATIENT AT PATIENT FOLLOW UP. NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    ASSOCIATED WITH COMPLAINT NUMBER (B)(4). FOLLOW UP REPORT IS BEING FILED TO CHANGE REPORTING DECISION FROM MALFUNCTION TO SERIOUS INJURY.REP REPORTED THAT THE SURGEON WAS UNABLE TO VISUALIZE ANY MARKERS ON X-RAY, UNABLE TO DETERMINE ORIENTATION AND UNABLE TO ACCURATELY DETERMINE SETTING VIA X-RAY. SURGEON DECIDED TO X-RAY THE PATIENT AT PATIENT FOLLOW UP. NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569579 CODMAN CERTAS INLINE VLV SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC MEDOS CMMBCY

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention