BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PV-INLINE W/SG [MH]

    MDR report key: 3952507 · Received July 23, 2014

    Report

    Report Number
    1226348-2014-11837
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. THE REVIEW OF THE DEVICES HISTORY RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. NO ROOT CAUSE COULD BE DETERMINED SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    DURING HYDROCEPHALY OPERATION, 82-3814 CATALOG NUMBER DEVICE WAS USED. TISSUE PARTS PASSED TO THE REGION WHERE THE VALVE MECHANISM IS AND DRAINAGE STOPPED. VALVE PIECE WAS TAKEN WITHOUT CLOSING PATIENT AND CONSIGNE SHUNT WHICH BELONGS TO DIFFERENT COMPANY WAS USED. (B)(4) 2014 AFFILIATE RESPONDED TO ADDITIONAL QUESTIONS AS FOLLOWS: DETAILS OF COMPLAINT/EVENT. DURING THE SURGERY, WHEN VENTRICULAR PART COMBINED TOGETHER WITH VALVE, WHITE PARTS WERE COMING INTO VALVE MECHANISM AND THERE WAS NO BOS FLOW AT THE PERITONEUM. WHAT WAS DONE TO SOLVE THE PROBLEM (WAS A NEW VALVE IMPLANTED ETC.)? CONSIGNEE VALVE WAS IMPLANTED . WAS THERE A PATIENT INJURY AS A RESULT OF THIS INCIDENT? ((B)6)). NO. WAS THERE A DELAY IN SURGERY GREATER THAN 30 (IF APPLICABLE/INCIDENT FOUND AT IMPLANT PROCEDURE)? ((B)(6)). LOT NUMBER OF VALVE ((B)(6)). UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430641 PV-INLINE W/SG [MH] SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF

    Patients

    Seq Age Sex Outcome Treatment
    1