BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER

    MDR report key: 4583171 · Received March 9, 2015

    Report

    Report Number
    1226348-2015-10150
    Event Type
    Injury
    Date Received
    March 9, 2015
    Date of Event
    February 11, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    JXG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLES WERE RETURNED FOR EVALUATION. IF THE SAMPLES ARE RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3100, WITH LOT CRGCK2, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 9TH JULY 2014. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3113, WITH LOT CRDCNG, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 24TH APRIL 2014. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3113, WITH LOT CRDBHF, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 10TH APRIL 2014. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3113, WITH LOT CRBDC5, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 17TH MARCH 2014. NO ROOT CAUSE COULD BE DETERMINED SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED. PLEASE ALSO SEE COMPLAINT (B)(4) FOR THE SECOND EVENT MENTIONED IN THE COMPLAINT.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT TWO CHPVS WHICH WERE RECENTLY IMPLANTED INTO PATIENTS WERE NO LONGER PROGRAMMABLE. HOSPITAL ASKED CODMAN TO TAKE BACK THE CHPVS WHICH ARE IN STOCK AT THE HOSPITAL FOR TESTING. ALSO SEE COMPLAINT (B)(4) AS THERE WAS MENTION OF TWO EVENTS INVOLVING TWO PATIENTS. DEAR ALL, PLEASE FIND ATTACHED A NEW COMPLAINT FOR CHPV FROM THE (B)(6) HOSPITAL IN (B)(6). THE HOSPITAL ASKED US TO TAKE BACK ALL THE CHPVS THEY HAVE CURRENTLY IN STOCK (11 CHPVS IN TOTAL) AND TEST THEM. ACCORDING TO THE SURGEON THEY REALIZED DURING THE PAST WEEKS THAT TWO VALVES WHICH WERE RECENTLY IMPLANTED WERE NO LONGER PROGRAMMABLE AND THEY HAVE CONCERN WHETHER THE DEVICES WHICH THEY HAVE IN STOCK ARE FUNCTIONING PROPERLY. THE TWO CHPVS THE HOSPITAL WAS REFERRING TO (I.E. NO LONGER PROGRAMMABLE) ARE STILL IMPLANTED AND THERE ARE NO PLANS SO FAR TO EXPLANT THEM BECAUSE BOTH PATIENTS ARE OK. I HAVE INFORMED OUR SALES REP TODAY THAT HE HAS TO ISSUE TWO NEW COMPLAINTS FOR EACH CHPV WITH THE ENCOUNTERED PROGRAMMING PROBLEM EVEN THOUGH THEY ARE STILL IMPLANTED. (B)(6) 2015 DEAR ALL, THE SALES REP IS TRYING TO GET THE FURTHER INFORMATION FROM THE HOSPITAL ON THE TWO CASES AND WILL ISSUE COMPLAINT REPORTS AS SOON AS SOON AS POSSIBLE. ACCORDING TO THE INFORMATION WE HAVE AT THE MOMENT THE TWO VALVES IN QUESTION ARE NOT PROGRAMMABLE BUT OPERATE ADEQUATELY, I.E. BOTH VALVES ARE ACTING AS NON-PROGRAMMABLE VALVES. SINCE THERE IS NO RISK FOR THE PATIENTS AT THE MOMENT, THE SURGEON DECIDED NOT TO EXPLANT THE VALVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162957 HAKIM PROGRAMMABLE VALVE WITH PRECHAMBER SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC CRGCK2

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention