BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE

    MDR report key: 3192293 · Received June 27, 2013

    Report

    Report Number
    1226348-2013-19641
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 30, 2013
    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

    EXAMINATION OF THE VALVE REVEALED THE PRESENCE OF BIOLOGICAL DEBRIS WITHIN THE DEVICE. THIS BIOLOGICAL DEBRIS CAUSED THE RETURNED VALVE TO FAIL THE PROGRAMMING TEST AND IT APPEARS TO HAVE CAUSED THE DIFFICULTY ENCOUNTERED BY THE CUSTOMER. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THE VALVE MET SPECIFICATION REQUIREMENTS WHEN RELEASED TO STOCK. 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

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT A (B)(6) PATIENT HAD HYDROCEPHALUS AND RECEIVED A MEDOS MICRO PROG VALVE IN (B)(6) 2013. PATIENT¿S DEVELOPED INCREASED INTRACRANIAL PRESSURE, AND AFTER MANY ATTEMPTS TO ADJUST THE PRESSURE, THE PATIENT DID NOT IMPROVE. AS A RESULT THE DEVICE WAS REMOVED EVEN AS THE SURGEON STATED THAT HE DID NOT BELIEVE THE DEVICE WAS BLOCKED. SUBSEQUENT TO THE REMOVAL OF THE DEVICE, THE PATIENT DEVELOPED AN INFECTION THAT IS BELIEVED TO HAVE CAUSED THE PATIENT¿S DEATH IN (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293557 HAKIM PROGRAMMABLE VALVE CNS SHUNT JXG CODMAN & SHURTLEFF, INC. CMGDMH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention