BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 3010835 · Received March 19, 2013

    Report

    Report Number
    1226348-2013-12788
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    January 26, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS NOT CLEAR IF THE DEVICE IS AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Additional Manufacturer Narrative · 1

    A FOLLOW UP REPORT IS BEING FILED AT THE ALERT DATE WAS INCORRECTLY REGISTERED. IT WAS INITIALLY REPORTED THAT THE ALERT DATE WAS (B)(6) 2013 WHEN IN FACT THAT WAS THE EVENT DATE. THE FIRST DATE J&J WAS MADE AWARE OF THE COMPLAINT WAS (B)(6) 2013. THE INITIAL REPORT WAS FILED ON TIME.

    Description of Event or Problem · 1

    REPORT RECEIVED FROM THE (B)(6) EXPLAINED THAT THIS VALVE WAS INSERTED ON (B)(6) 2013 AT 18:55, THE CHILD CONTINUED TO DETERIORATE SO THEY CAME BACK TO THEATRE ON (B)(6) 2013 FOR VENTRICULO-PERITONEAL SHUNT REVISION. THEY DISCOVERED THAT THE VALVE WAS DAMAGED (FRACTURED) AT THE DISTAL END AND WAS THEREFORE LEAKING CEREBRO SPINAL FLUID. DETAILS OF INJURY TO CHILD INCLUDE INCREASED DROWSINESS AND VOMITING. PATIENT CONTINUED TO DETERIORATE UNTIL THE NEW VALVE WAS INSERTED ON (B)(6) 2013.

    Description of Event or Problem · 1

    A FOLLOW UP REPORT IS BEING FILED AT THE ALERT DATE WAS INCORRECTLY REGISTERED. IT WAS INITIALLY REPORTED THAT THE ALERT DATE WAS (B)(6) 2013 WHEN IN FACT THAT WAS THE EVENT DATE. THE FIRST DATE J&J WAS MADE AWARE OF THE COMPLAINT WAS (B)(6) 2013. THE INITIAL REPORT WAS FILED ON TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113339 CERTAS INLIN VLV ONLY W/SPHNGD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC CNHCZT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention