BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 4634678 · Received March 26, 2015

    Report

    Report Number
    1226348-2015-10185
    Event Type
    Injury
    Date Received
    March 26, 2015
    Date of Event
    March 16, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK980778
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 82-3113, WITH LOT CKKCRJ, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 18TH SEPTEMBER 2009. NO ROOT CAUSE COULD BE DETERMINED SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. BASED ON THE RESULTS OF THE INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    SURGEON AND NURSE PRACTITIONER UNABLE TO GET CHPV TO REPROGRAM FROM CURRENT SETTING (120) TO DESIRED SETTING (60). VPV REPROGRAMMER WOULD NOT GIVE ACOUSTIC VERIFICATION. AFTER MULTIPLE ATTEMPTS THE PATIENT WAS SENT TO X-RAY AND IT WAS CONFIRMED THAT SHUNT WAS STILL SET AT 120. (B)(4) REP WAS BROUGHT IN TO ASSIST WITH REPROGRAMMING (B)(6) 2015 AND AFTER MULTIPLE ATTEMPTS THE SHUNT WAS STILL SET AT 120. THIS WAS CONFIRMED BY X-RAY. STILL IMPLANTED. ON 3/23/2015 ADDITIONAL INFORMATION EXPLAINED, AT THIS POINT THE LIKELY COURSE OF ACTION IS A REVISION; HOWEVER, THE CLINICIAN AND THE FAMILY HAVE NOT DECIDED AT WHICH POINT THIS WILL OCCUR. TO THE BEST OF MY KNOWLEDGE THEY HAVE NOT BROUGHT IN A BACKUP UNIT YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203959 HAKIM PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CKKCRJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention