BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 4808581 · Received June 1, 2015

    Report

    Report Number
    1226348-2015-10304
    Event Type
    Injury
    Date Received
    June 1, 2015
    Date of Event
    May 5, 2015
    Manufacturer
    JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A
    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

    IT WAS NOT POSSIBLE TO INVESTIGATE THE PRODUCTS SINCE THEY WERE NOT RETURNED FOR EVALUATION. IF THE DEVICES ARE RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3114 WITH LOT CRCC05, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE APRIL 24TH, 2014. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE CATHETER PRODUCT CODE 82-3072 WITH LOT CRJB8K, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE AUGUST 20TH, 2014. 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.

    Description of Event or Problem · 1

    THE PATIENT IS MALE AND (B)(6) YEARS OLD, DID V-P SURGERY ON (B)(6) 2015. THE PATIENT NOTED LEAKAGE OF LIQUID FROM BELLY. IT WAS REPORTED THAT PATIENT HAD SUBCUTANEOUS INFECTION. THE SURGEON INTENDED TO DO THE TREATMENT OF INFLAMMATION AND REMOVE THE PROGRAMMER. THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352124 HAKIM PROGRAMMABLE VALVE CNS SHUNT JXG JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A CRCC05

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention