BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 4712502 · Received April 21, 2015

    Report

    Report Number
    1226348-2015-10237
    Event Type
    Injury
    Date Received
    April 21, 2015
    Date of Event
    March 1, 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

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE, IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE 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 82-3114, WITH LOT CPJBD0, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 6TH SEPTEMBER 2013. 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.

    Description of Event or Problem · 1

    VALVE OBSTRUCTION ISSUE. THE PATIENT IS (B)(6) YEARS OLD, DID V-P SURGERY IN YR 2014. DEVICE 823114 WAS USED AND NO ABNORMALITY WAS NOTED DURING THE SURGERY. THE PATIENT FELT DIZZINESS ACCOMPANIED BY VOMITING AT THE EARLY OF LUNAR YEAR 2015. THE SURGEON ADJUSTED THE PRESSURE OF THE VALVE BUT WITHOUT ANY EFFECT. IT WAS SUSPECTED THE VALVE WAS OBSTRUCTED DUE TO HIGH CEREBRAL PROTEIN. THE PATIENT IS STILL IN HOSPITAL AND WAITING FOR REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265226 HAKIM PROGRAMMABLE VALVE CNS SHUNT JXG JOHNSON AND JOHNSON PROFESSIONAL, INC. / MEDOS S.A CPJBD0

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Required Intervention