BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 3823755 · Received May 21, 2014

    Report

    Report Number
    1226348-2014-11614
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    September 12, 2013
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. AN INITIAL MEDWATCH IS BEING GENERATED TO FILE THIS COMPLAINT AS A MALFUNCTION. UPON COMPLETION OF THE INVESTIGATION, THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND WAS FOUND TO WORK IN ACCORDANCE WITH THE MANUFACTURING SPECIFICATIONS. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTIONS. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED. ATTEMPTED TO SUBMIT ON MAY 14, 2014 AS PART OF THE FDA REMEDIATION PROJECT. REPORT WAS STUCK ON FIRST ACKNOWLEDGEMENT DUE TO FDA SYSTEM ISSUES. FDA INSTRUCTED TO RESUBMIT COMPLAINTS THAT WERE UNSUCCESSFULLY SUBMITTED. 5/21/2014.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE HOSPITAL SAID THAT WHEN THEY TESTED THE VALVE IT WAS NOT WORKING PROPERLY. THE SALINE DID NOT GO THROUGH THE VALVE IN PRE TESTING. DID NOT OCCUR DURING A SURGERY. WE RECENTLY REVISED OUR MDR REPORTING PROCEDURES BASED ON FEEDBACK FROM A RECENT FDA AUDIT THAT WAS CONDUCTED IN 2013. ONCE THE CHANGES WERE MADE TO THE PROCEDURES, WE CONDUCTED RETROSPECTIVE REVIEW OF OUR PRODUCT COMPLAINTS AND MDR FILES. THE ATTACHED MDR REPORT IS BEING FILED AS RESULT OF THOSE CHANGES WE MADE TO OUR INTERNAL MDR REPORTING PROCEDURES. AN INITIAL MEDWATCH IS BEING GENERATED TO FILE THIS COMPLAINT AS A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302283 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPDBLH

    Patients

    Seq Age Sex Outcome Treatment
    1