BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CERTAS INLINE W/SPHNGD/BAC CAT

    MDR report key: 3790019 · Received May 5, 2014

    Report

    Report Number
    1226348-2014-11532
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 13, 2012
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK112156
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE VALVE WAS LEAK TESTED, AND CONFIRMED A LEAK IN THE SIDE OF THE VALVE AT THE DISTAL END. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. THE PRODUCTION TEAM WAS INFORMED OF THIS PROBLEM AND WAS RETRAINED IN THIS PROCESS. A REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE SPECIFICATIONS PRIOR TO DISTRIBUTION. BASED ON THE INVESTIGATION THIS COMPLAINT IS CONSIDERED CLOSED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR EVENTS.

    Description of Event or Problem · 1

    AFTER IMPLANTATION OF CERTAS VALVE, WITH VENTRICULAR AND PERITONEAL CATHETER ATTACHED TO THE VALVE, THE SURGEON RECOGNIZED THAT THERE WAS A SMALL HOLE IN THE VALVE, BUBBLES AND CSF CAME OUT OF THE CHAMBER. THE SURGEON IS VERY EXPERIENCED, SHE DID NOT USE ANY INSTRUMENTS UNDER THE OPERATION. PATIENT OK, RECEIVED A NEW VALVE. IMPLANTATION DATE: (B)(6) 2012. EXPLANTATION DATE: (B)(6) 2012. ADDITIONAL INFORMATION (B)(4) 2012: THE DEVICE WAS REVISED DURING AN INTRA-OPERATIVE PROCEDURE AND BEFORE WOUND CLOSURE WITH NO DELAY GREATER THAN 30 MINUTES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268968 CERTAS INLINE W/SPHNGD/BAC CAT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CMDDJV

    Patients

    Seq Age Sex Outcome Treatment
    1