BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE, RT ANGLE

    MDR report key: 4093438 · Received September 16, 2014

    Report

    Report Number
    1226348-2014-11972
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    May 1, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IT HAS BEEN COMMUNICATED THAT THE DEVICE AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION 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

    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. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3184, WITH LOT NUMBER CPJBF7, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 4TH SEPTEMBER 2013. NO ROOT CAUSE COULD BE DETERMINED SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINT. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. ON (B)(6) 2014, PROVIDED INFORMATION REGARDING THE PRODUCT CODE NUMBER, LOT NUMBER, SHUNT PLACEMENT DATE AND SHUNT REVISION DATE FOR THIS COMPLAINT.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. INFORMED THAT: "MY SURGEON NOTIFIED ME YESTERDAY AFTERNOON THAT HE HAS THREE PATIENTS WHO RECEIVED SHUNTS OVER THE PAST SIX MONTHS WHO ARE SEVERELY OVER SHUNTING AND IT HAS CAUSED A COLLAPSE IN VENTRICLES ON EACH PATIENT¿. ADDITIONAL INFORMATION: ¿PATIENT HAD HIS VP SHUNT PUT IN FOR NPH ON (B)(6) 2013. PT HAD SOME COMPLICATIONS WITH DISTAL TUBING BECOMING BLOCKED. WE REVISED HIS VP SHUNT IN (B)(6) 2014 THEN CHANGED DISTAL TUBING IN (B)(6) 2014". (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571519 HAKIM PROGRAMMABLE VALVE, RT ANGLE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CPJBF7

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention